A Phase 3 interventional study of Fecal Microbiota Transplantation and Vancomycin in Clostridium Difficile, sponsored by Memorial University of Newfoundland. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Memorial University of Newfoundland · Phase 3, Interventional, and Treatment
Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.
Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
Browse Clostridium Infections studies →Memorial University of Newfoundland is the lead sponsor of 46 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Oral, encapsulated fecal microbiota transplantation
Biological: Fecal Microbiota Transplantation · Drug: Vancomycin Placebo
125 mg po qid x 10 days
Drug: Vancomycin · Biological: Fecal Microbiota Transplantation Placebo
Oral, encapsulated FMT
Also known as: Stool Transplant
Vancomycin po 125 mg qid x 10 days
Also known as: Vancocin
Matching placebo to FMT
Also known as: Stool Transplant Placebo
Matching placebo to Vancomycin
Also known as: Vancocin Placebo
Efficacy: Cure of diarrhea without recurrence in intention to treat population
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
Time frame: 56 days
Adverse Events
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Time frame: 56 days
Efficacy: Cure of diarrhea without recurrence in a per protocol population
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
Time frame: 56 days
Efficacy: cure of diarrhea in intention to treat and per protocol populations
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Time frame: 10 days
Efficacy: time to cure of diarrhea
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Time frame: 56 days
Efficacy: Health status questionnaire
Time frame: 56 days
Plan to share: Yes — After analysis is completed, data will be released
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Memorial University of Newfoundland