Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-03 @ 9:04 AM
Study NCT ID:
NCT01398969
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D003967', 'term': 'Diarrhea'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants received either FMT or placebo to prevent further episode of CDI following FMT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-20', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of the safety of HBT', 'timeFrame': '13 Weeks post HBT', 'description': 'Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.'}, {'measure': 'To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT.', 'timeFrame': '13 Weeks post HBT'}], 'secondaryOutcomes': [{'measure': 'To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT.', 'timeFrame': '13 Weeks post HBT'}, {'measure': 'Assessment of the functional health and well-being of patients', 'timeFrame': 'Up to 1 year', 'description': 'Patients will be asked to fill in the self-administered Health Survey at baseline, week 5, week 13 and 1 year from last HBT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized', 'Double Blind', 'Fecal Transplant', 'Recurrent', 'Clostridium difficile infection', 'CDI', 'HBT', 'Diarrhea', 'Frozen HBT', 'Thawed HBT', 'Fecal Enema'], 'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '26757463', 'type': 'DERIVED', 'citation': 'Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient inclusion criteria\n\n1. Age 18 years or older.\n2. Able to provide informed consent.\n3. Laboratory or pathology: confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.\n4. ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.\n\nSymptoms of CDI, diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is defined as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.\n\nPatient exclusion criteria\n\n1. Planned or actively participating in another clinical trial.\n2. Patients with neutropenia with absolute neutrophil count \\<0.5 x 109/L\n3. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray\n4. Peripheral white blood cell count \\> 30.0 x 10E9/L AND temperature \\> 38.0 oC\n5. Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.\n6. Presence of colostomy\n7. Unable to tolerate HBT or enema for any reason.\n8. Requiring systemic antibiotic therapy for more than 7 days.\n9. Actively taking Saccharomyces boulardii\n10. Severe underlying disease such that the patient is not expected to survive for at least 30 days.\n11. Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.\n\nDonor inclusion\n\n1. Able to provide and sign informed consent.\n2. Able to complete and sign the donor questionnaire\n3. Able to adhere to fecal transplantation stool collection standard operating procedure.\n\nDonor exclusion\n\n1. Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.\n2. Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination\n3. History of any type of active cancer or autoimmune disease\n4. History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.\n5. History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea\n6. Receipt of blood transfusion from a country other than Canada in preceding 6 months\n7. Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation\n8. Receipt of any type of live vaccine within 3 months prior to stool donation\n9. Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.\n10. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor'}, 'identificationModule': {'nctId': 'NCT01398969', 'briefTitle': 'Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'CDI.HBT.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fresh FMT', 'description': 'Participants in this arm will receive Fresh FMT via rectal administration. They will be followed for 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.', 'interventionNames': ['Biological: Fresh FMT']}, {'type': 'EXPERIMENTAL', 'label': 'Frozen-and-Thawed FMT', 'description': 'Participants in this arm will receive Frozen-and-Thawed FMT via rectal administration. They will be followed 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.', 'interventionNames': ['Biological: Frozen-and-Thawed FMT']}], 'interventions': [{'name': 'Fresh FMT', 'type': 'BIOLOGICAL', 'otherNames': ['Fresh Fecal Transplantation (FMT)'], 'description': 'Participants will receive fresh FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed', 'armGroupLabels': ['Fresh FMT']}, {'name': 'Frozen-and-Thawed FMT', 'type': 'BIOLOGICAL', 'otherNames': ['Frozen-and-Thawed Fecal Transplantation (FMT)'], 'description': 'Participants will receive frozen-and-thawed FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed', 'armGroupLabels': ['Frozen-and-Thawed FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Coastal Health (VCHRI/VCHA) - Diamond Health Care Centre and Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Christine Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Healthcare Hamilton"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, {'name': 'Kingston Health Sciences Centre', 'class': 'OTHER'}, {'name': "Queen's University", 'class': 'OTHER'}, {'name': 'Vancouver General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}