Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-09 @ 2:45 AM
Study NCT ID:
NCT03788434
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2018-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ConsortiumIO-ctinquiries@vedantabio.com', 'phone': '(857) 706-1427', 'title': 'Jeffrey Silber', 'organization': 'Vedanta Biosciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 28, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 243, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 213, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 114, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Potassium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CDI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Escherichia Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CDI Recurrence Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'title': 'C. difficile recurrences (toxin-positive)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VE303 Strains Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'spread': '2.807', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '1.962', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.633', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Characterize the number of VE303 strains detected in the fecal microbiome at week 24.', 'unitOfMeasure': 'Number of VE303 strains detected', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects who provided stool samples for analysis at week 24.'}, {'type': 'SECONDARY', 'title': 'VE303 Relative Abundance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01186', 'spread': '0.013897', 'groupId': 'OG000'}, {'value': '0.00775', 'spread': '0.016007', 'groupId': 'OG001'}, {'value': '0.00097', 'spread': '0.002297', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.', 'unitOfMeasure': 'Proportion of VE303 strains', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects who provided stool samples for analysis at week 24.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CDI Recurrence Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'title': 'C. difficile recurrences (toxin-positive)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CDI Recurrence Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'title': 'C. difficile recurrences (toxin-positive)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CDI Recurrence Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'classes': [{'title': 'C. difficile recurrences (toxin-positive)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Microbiota Diversity', 'timeFrame': '24 weeks', 'description': 'Characterize the fecal microbiome Shannon Diversity at week 24.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Determine the Recommended VE303 Phase 3 Dose Regimen(s).', 'timeFrame': '31 Months 1 Week', 'description': 'Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.', 'timeFrame': '31 Months 1 Week', 'description': 'Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taxonomic Composition', 'timeFrame': '31 Months, 1 Week', 'description': 'Characterize Taxonomic Composition', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'FG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VE303 High Dose', 'description': 'Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'BG001', 'title': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days.\n\nVE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.\n\nPlacebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '14.99', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '17.85', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '15.98', 'groupId': 'BG002'}, {'value': '62.1', 'spread': '16.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-15', 'size': 3600453, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-16T13:06', 'hasProtocol': True}, {'date': '2021-07-15', 'size': 908096, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-16T13:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors were masked to study treatment assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This Phase 2 study evaluated the safety and efficacy of the study drug, VE303, at preventing subsequent CDI-associated diarrhea compared with placebo, following completion of at least 1 successful course of SOC antibiotics for subjects with pCDI at high risk for recurrence or subjects with rCDI.\n\nParticipants in the study were randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2018-12-19', 'resultsFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-29', 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CDI Recurrence Week 4', 'timeFrame': '4 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment).'}, {'measure': 'CDI Recurrence Week 12', 'timeFrame': '12 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment).'}, {'measure': 'CDI Recurrence Week 24', 'timeFrame': '24 Weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).'}, {'measure': 'Microbiota Diversity', 'timeFrame': '24 weeks', 'description': 'Characterize the fecal microbiome Shannon Diversity at week 24.'}, {'measure': 'Determine the Recommended VE303 Phase 3 Dose Regimen(s).', 'timeFrame': '31 Months 1 Week', 'description': 'Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study.'}, {'measure': 'Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.', 'timeFrame': '31 Months 1 Week', 'description': 'Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.'}, {'measure': 'Taxonomic Composition', 'timeFrame': '31 Months, 1 Week', 'description': 'Characterize Taxonomic Composition'}], 'primaryOutcomes': [{'measure': 'CDI Recurrence Week 8', 'timeFrame': '8 weeks', 'description': 'Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).'}], 'secondaryOutcomes': [{'measure': 'VE303 Strains Detected', 'timeFrame': '24 weeks', 'description': 'Characterize the number of VE303 strains detected in the fecal microbiome at week 24.'}, {'measure': 'VE303 Relative Abundance', 'timeFrame': '24 weeks', 'description': 'Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium Difficile Infection Recurrence', 'Clostridium Difficile Infection', 'Clostridium Difficile', 'VE303', 'Consortium', 'Vedanta', 'CDI', 'C. Diff', 'CDiff', 'Clostridiodes Difficile Infection Recurrence', 'Clostridiodes Difficile Infection', 'Clostridioides Difficile'], 'conditions': ['Clostridium Difficile Infection Recurrence', 'Clostridium Difficile Infection', 'Clostridium Difficile', 'Clostridioides Difficile Infection Recurrence', 'Clostridioides Difficile Infection', 'Clostridioides Difficile', 'CDI']}, 'referencesModule': {'references': [{'pmid': '37060545', 'type': 'DERIVED', 'citation': 'Louie T, Golan Y, Khanna S, Bobilev D, Erpelding N, Fratazzi C, Carini M, Menon R, Ruisi M, Norman JM, Faith JJ, Olle B, Li M, Silber JL, Pardi DS. VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection: A Randomized Clinical Trial. JAMA. 2023 Apr 25;329(16):1356-1366. doi: 10.1001/jama.2023.4314.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).', 'detailedDescription': 'CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention of subsequent Clostridioides difficile infection (CDI) -associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI recurrence within 8 weeks after the first dose of study treatment were compared across the study arms, to understand the efficacy of VE303 in preventing rCDI.\n\nThe study originally planned to enroll 146 subjects but through a protocol amendment was revised to an enrollment target of 60 to 80 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must have had a positive C. difficile stool sample and have responded to SOC antibiotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Partial Inclusion Criteria:\n\n1. Able and willing to provide written informed consent\n2. Subjects with a qualifying CDI episode who had a prior history of CDI diarrhea (≥ 18 years of age) or first occurrence of CDI diarrhea with a higher risk for recurrence (≥ 75 years of age, or ≥ 65 years of age with one or more prespecified conditions)\n3. CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization\n4. The diarrhea was considered unlikely to have another etiology.\n5. Completed an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration\n6. Have a positive C. difficile stool\n7. Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization.\n\nPartial Exclusion Criteria:\n\n1. History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4 weeks) that was not related to C. difficile infection within the 3 months prior to randomization.\n2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization.\n3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus).\n4. Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea\n5. History of administration of fecally-derived investigational live biotherapeutic products, or fecally-derived live bacterial isolates for CDI-associated diarrhea including fecal microbiota transplantation (FMT) within the last 6 months.\n6. Use of drugs that alter gut motility\n7. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.\n8. Subjects with compromised immune system\n9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.\n10. History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia."}, 'identificationModule': {'nctId': 'NCT03788434', 'acronym': 'CONSORTIUM', 'briefTitle': 'Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vedanta Biosciences, Inc.'}, 'officialTitle': 'CONSORTIUM - A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection', 'orgStudyIdInfo': {'id': 'CONSORTIUM (VE303-002)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VE303 High Dose', 'description': 'Study subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10\\^9 CFU daily) containing VE303 per day for 14 days.', 'interventionNames': ['Drug: VE303']}, {'type': 'EXPERIMENTAL', 'label': 'VE303 Low Dose', 'description': 'Study subjects assigned to the low dose VE303 arm took 2 capsules (dosage: 1.6 × 10\\^9 CFU daily) containing VE303 per day for 14 days.', 'interventionNames': ['Drug: VE303']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VE303', 'type': 'DRUG', 'description': 'VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.', 'armGroupLabels': ['VE303 High Dose', 'VE303 Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Clinical, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic, Clinical Studies Unit', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research Institute', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 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