Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-18 @ 1:34 AM
Study NCT ID:
NCT04266106
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics and Recovery From Gastrointestinal Surgery - 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'up to 2 months', 'description': 'Functional Assessment of Cancer Therapy (FACT) G7 score: higher value corresponds with better QoL, range 0-28 points'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Recovery']}, 'referencesModule': {'references': [{'pmid': '31562911', 'type': 'BACKGROUND', 'citation': 'Franko J, Raman S, Krishnan N, Frankova D, Tee MC, Brahmbhatt R, Goldman CD, Weigel RJ. Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation. J Am Coll Surg. 2019 Dec;229(6):533-540.e1. doi: 10.1016/j.jamcollsurg.2019.09.002. Epub 2019 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years undergoing elective major abdominal operation\n* Functional GI tract expected after operation\n\nExclusion Criteria:\n\n* Current episode of acute necrotizing pancreatitis as defined by surgeon\n* Palliative decompressive GI tube\n* Life expectancy ≤ 6 months\n* Systemic immune-mediated disease active requiring systemic therapy:\n* Prednisone ≥20 mg QD\n* IV immunoglobulins\n* Anti-rejection medication\n* Presence of functional transplanted organ\n* Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.\n* Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed\n* Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle\n* Need for full systemic anticoagulation postoperatively.'}, 'identificationModule': {'nctId': 'NCT04266106', 'acronym': 'PROGRESS-2', 'briefTitle': 'Probiotics and Recovery From Gastrointestinal Surgery - 2', 'organization': {'class': 'OTHER', 'fullName': 'MercyOne Des Moines Medical Center'}, 'officialTitle': 'Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2', 'orgStudyIdInfo': {'id': 'MMC-2019-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'probiotic', 'interventionNames': ['Drug: SuperBio probiotic']}], 'interventions': [{'name': 'SuperBio probiotic', 'type': 'DRUG', 'description': 'One capsule po BID for 28 days', 'armGroupLabels': ['probiotic']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One capsule po BID for 28 days', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'MercyOne Des Moines Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}], 'centralContacts': [{'name': 'Jan Franko', 'role': 'CONTACT', 'email': 'jfranko@mercydesmoines.org', 'phone': '5152473266'}], 'overallOfficials': [{'name': 'Jan Franko', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MercyOne Des Moines Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan Franko, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'SuperBio', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair of Surgical Oncology', 'investigatorFullName': 'Jan Franko, MD', 'investigatorAffiliation': 'MercyOne Des Moines Medical Center'}}}}