Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT01972334
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-23', 'releaseDate': '2020-09-03'}, {'resetDate': '2024-02-27', 'releaseDate': '2024-01-31'}, {'resetDate': '2024-05-07', 'releaseDate': '2024-04-15'}], 'estimatedResultsFirstSubmitDate': '2020-09-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005457', 'term': 'Fluoridation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2013-10-24', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy outcome of this randomized, controlled, double-blinded study is the time of recurrence of an infection', 'timeFrame': '12 months', 'description': 'secondary outcome measures are focused on the safety of Fecal microbial transplant in this population and all subjects will be closely monitored for developing adverse events for 12 months'}], 'secondaryOutcomes': [{'measure': 'safety of fecal microbial transplant in children with recurrent clostridium difficile', 'timeFrame': '12 months', 'description': 'All subjects will be closely monitored for adverse events for 12 months after fecal transplant. Subjects will be asked to report any adverse events as they occur and will also be monitored during each visits especially fever, bloating, abdominal pain, vomiting, diarrhea, and rectal bleeding.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clostridium difficile', 'children', 'fecal transplant'], 'conditions': ['Clostridium Difficile Colitis']}, 'descriptionModule': {'briefSummary': 'The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.', 'detailedDescription': 'Forty six children with recurrent C. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. The safety and efficacy of this intervention will be monitored for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 1-21.\n2. Recurrent C. difficile infection defined as the occurrence of more than two infections\n\nExclusion Criteria:\n\n1. Inflammatory bowel disease\n2. Immune-deficiency.\n3. Allergy to oral vancomycin.\n4. Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.\n5. Concurrent infections that require anti-microbial therapy.\n6. Unable to give informed consent/assent.\n7. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT01972334', 'briefTitle': 'Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection', 'organization': {'class': 'OTHER', 'fullName': 'MemorialCare Health System'}, 'officialTitle': 'A Randomized, Placebo-controlled Pilot Trial to Administer Fecal Microbial Therapy (Stool Transplant) or Placebo in Children Ages 8 to 18 With Recurrent C. Difficile Infection', 'orgStudyIdInfo': {'id': '093-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT or fecal microbial transplant', 'description': 'intervention is fecal microbial transplant done through endoscopy, subjects will be randomized 1:1 to receive either FMT or placebo', 'interventionNames': ['Biological: FMT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1:1 randomization to FMT versus placebo (which is saline or salt water)', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'FMT', 'type': 'BIOLOGICAL', 'otherNames': ['fecal microbial transplant', 'stool transplant'], 'description': 'as explained in study arm', 'armGroupLabels': ['FMT or fecal microbial transplant']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'otherNames': ['saline', 'salt water'], 'description': 'salt water or saline will be given as placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Sonia Michail, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MemorialCare Health Servies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MemorialCare Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Medical Center Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sonia Michail, MD', 'investigatorAffiliation': 'MemorialCare Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-03', 'type': 'RELEASE'}, {'date': '2020-09-23', 'type': 'RESET'}, {'date': '2024-01-31', 'type': 'RELEASE'}, {'date': '2024-02-27', 'type': 'RESET'}, {'date': '2024-04-15', 'type': 'RELEASE'}, {'date': '2024-05-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sonia Michail, MD, MD, MemorialCare Health System'}}}}