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Ignite Creation Date: 2025-12-25 @ 2:55 AM

Ignite Modification Date: 2026-01-08 @ 2:18 AM

Study NCT ID: NCT03110133

Status: COMPLETED

Last Update Posted: 2022-10-05

First Post: 2017-04-03

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D020790', 'term': 'Diabetes Insipidus, Neurogenic'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbudree@finchtherapeutics.com', 'phone': '(857) 322-4646', 'title': 'Dr. Shrish Budree', 'phoneExt': '646', 'organization': 'Finch Therapeutics'}, 'certainAgreement': {'otherDetails': 'The disclosure restrictions on the PI are: (i) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to eighteen months from the lock-down of all study data and (ii) the sponsor can require the removal of its confidential information from results communications and may delay release for a period of up to 60 days for the purpose of filing patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'Based on Safety population', 'eventGroups': [{'id': 'EG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 97, 'seriousNumAtRisk': 104, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 92, 'seriousNumAtRisk': 99, 'deathsNumAffected': 2, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pus in stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metapneumovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleurisy viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Volvulus of small bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0488', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Defined in the protocol as sustained clinical cure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Occurrence of Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Time to First Recurrent CDI Episode During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '6.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The number of days between IP administration and the first C. Difficile recurrence', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0347', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Defined in the protocol as sustained clinical cure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'classes': [{'categories': [{'title': 'Ribosomal NAP1/BI/027 Positive at Recurrence', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Ribosomal NAP1/BI/027 Negative or Unknown at Recurrence', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'description': 'NAP1 is the North American Pulse-field C. difficile subtype.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population only included participants with a CDI recurrence up to week 8. Two of the recurrences in the primary efficacy analyses were imputed, therefore only 24 samples were available for this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}], 'periods': [{'title': 'Week 8', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CP101', 'description': 'Full Spectrum Microbiota Capsule\n\nFull Spectrum Microbiota: Orally administered donor derived microbiota'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching Placebo Capsule\n\nPlacebo: Placebo for CP101'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '17.26', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '14.25', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '15.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': '>3', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent to Treat (mITT) population used'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-01', 'size': 2066922, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-25T14:34', 'hasProtocol': True}, {'date': '2021-04-12', 'size': 1493530, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-25T14:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2017-04-03', 'resultsFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-10', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication', 'timeFrame': 'Week 8', 'description': 'Defined in the protocol as sustained clinical cure'}, {'measure': 'Number of Participants With Occurrence of Treatment Emergent Adverse Events', 'timeFrame': 'Week 8', 'description': 'Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)'}], 'secondaryOutcomes': [{'measure': 'Time to First Recurrent CDI Episode During the Study', 'timeFrame': 'Week 8', 'description': 'The number of days between IP administration and the first C. Difficile recurrence'}, {'measure': 'Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication', 'timeFrame': 'Week 24', 'description': 'Defined in the protocol as sustained clinical cure'}, {'measure': 'Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype', 'timeFrame': 'Up to Week 8', 'description': 'NAP1 is the North American Pulse-field C. difficile subtype.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium Difficile Infection', 'CP101', 'Crestovo', 'FMT', 'CDI', 'C. difficile', 'C. diff', 'Recurrent Clostridium Difficile Infection', 'Recurrent C. diff', 'Recurrent CDI', 'Finch', 'Fecal transplant', 'Fecal microbiota transplant', 'rCDI', 'Finch Therapeutics'], 'conditions': ['Clostridium Difficile Infection Recurrence']}, 'referencesModule': {'references': [{'pmid': '39366468', 'type': 'DERIVED', 'citation': 'Allegretti JR, Kelly CR, Louie T, Fischer M, Hota S, Misra B, Van Hise NW, Yen E, Bullock JS, Silverman M, Davis I, McGill SK, Pardi DS, Orenstein R, Grinspan A, El-Nachef N, Feuerstadt P, Borody TJ, Khanna S, Budree S, Kassam Z. Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial. Gastroenterology. 2025 Feb;168(2):357-366.e3. doi: 10.1053/j.gastro.2024.09.030. Epub 2024 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.\n\nSubjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.', 'detailedDescription': 'This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Men or women 18 years of age or older\n* Current diagnosis of a recurrence of non-severe, non-complicated CDI\n* Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode\n\nExclusion Criteria:\n\n* Pregnant, breast-feeding, or considering becoming pregnant during the study\n* Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)\n* Any prior diagnosis of diarrhea-predominant irritable bowel syndrome\n* Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization\n* Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study\n* Major intra-abdominal surgery within the past 60 days prior to Screening\n* History of total colectomy/ileostomy or bariatric surgery\n* Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry\n* Planned hospitalization or invasive surgery during the study\n* Severe acute illness unrelated to CDI"}, 'identificationModule': {'nctId': 'NCT03110133', 'acronym': 'PRISM3', 'briefTitle': 'Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff', 'organization': {'class': 'INDUSTRY', 'fullName': 'Finch Research and Development LLC.'}, 'officialTitle': 'A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'CDI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP101', 'description': 'Full Spectrum Microbiota Capsule', 'interventionNames': ['Drug: Full Spectrum Microbiota']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo Capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Full Spectrum Microbiota', 'type': 'DRUG', 'otherNames': ['CP101, FSM'], 'description': 'Orally administered donor derived microbiota', 'armGroupLabels': ['CP101']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for CP101', 'armGroupLabels': 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