Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT02743234
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D000077732', 'term': 'Fidaxomicin'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment', 'timeFrame': '8 weeks', 'description': 'Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment'}], 'secondaryOutcomes': [{'measure': 'Number of patients with clinical resolution 1 week after primary treatment', 'timeFrame': '1 week', 'description': 'Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 1 week after finishing allocated treatment'}, {'measure': 'Number of patients with clinical resolution 8 weeks after primary treatment', 'timeFrame': '8 weeks', 'description': 'Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with clinical resolution 26 weeks after primary treatment', 'timeFrame': '26 weeks', 'description': 'Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with microbiological resolution week 1', 'timeFrame': '1 week', 'description': 'Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with microbiological resolution week 8', 'timeFrame': '8 weeks', 'description': 'Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with microbiological resolution week 26', 'timeFrame': '26 weeks', 'description': 'Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with global resolution (Clinical and microbiological resolution) week 1', 'timeFrame': '1 week', 'description': 'Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 1 week after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Number of patients with global resolution (Clinical and microbiological resolution) week 26', 'timeFrame': '26 weeks', 'description': 'Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy'}, {'measure': 'Numerical change in quality of life (EQ5D-3L) week 8 and 26', 'timeFrame': '8 and 26 weeks', 'description': 'EQ5D-3L (www.euroqol.com) measures self-reported quality of life in 5 dimensions (each three levels), rendering score from 5 (lowest and best) to 15 (highest and worst) plus an overall reporting of general well being (0, lowest, worst to 100, highest, best). Scoring is obtained week 0,8,26 after randomization. Numerical changes are documented and compared using non-parametric statistics'}, {'measure': 'Microbiota pattern changes 1, 8 and 26 weeks', 'timeFrame': '1, 8 and 26 weeks', 'description': 'Microbiota profiling, 16S rRNA, absence or presence of specific genera'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '35463939', 'type': 'DERIVED', 'citation': 'Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Therap Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.'}, {'pmid': '30610862', 'type': 'DERIVED', 'citation': 'Hvas CL, Dahl Jorgensen SM, Jorgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. Does not speak or understand the Danish language\n3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin\n4. fulminant colitis which contraindicates medical treatment\n5. physician's evaluation that the patient cannot tolerate project inclusion"}, 'identificationModule': {'nctId': 'NCT02743234', 'acronym': 'FACIT', 'briefTitle': 'Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'FACIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT', 'description': 'Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor', 'interventionNames': ['Other: Fecal microbiota transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fidaxomicin', 'description': '10 days fidaxomicin 200 mg x 2 daily', 'interventionNames': ['Drug: Fidaxomicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': '10 days vancomycin 125 x 4 daily', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Fecal microbiota transplantation', 'type': 'OTHER', 'description': 'FMT follows 4-10 days of vancomycin 125 mg x 4 daily', 'armGroupLabels': ['FMT']}, {'name': 'Fidaxomicin', 'type': 'DRUG', 'description': 'Fidaxomicin 200 mg x 2 daily for 10 days', 'armGroupLabels': ['Fidaxomicin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin 125 mg x 4 daily for 10 days', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Jens F Dahlerup, MD DrMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}