Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fecal Microbiota Transplantation

Oral, encapsulated fecal microbiota transplantation

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type BIOLOGICAL

Oral, encapsulated FMT

Vancomycin Placebo

Intervention Type DRUG

Matching placebo to Vancomycin

Vancomycin

125 mg po qid x 10 days

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin po 125 mg qid x 10 days

Fecal Microbiota Transplantation Placebo

Intervention Type BIOLOGICAL

Matching placebo to FMT

Interventions

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Fecal Microbiota Transplantation

Oral, encapsulated FMT

Intervention Type BIOLOGICAL

Vancomycin

Vancomycin po 125 mg qid x 10 days

Intervention Type DRUG

Fecal Microbiota Transplantation Placebo

Matching placebo to FMT

Intervention Type BIOLOGICAL

Vancomycin Placebo

Matching placebo to Vancomycin

Intervention Type DRUG

Other Intervention Names

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Stool Transplant Vancocin Stool Transplant Placebo Vancocin Placebo

Eligibility Criteria

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Inclusion Criteria

* life expectancy \> 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization

Exclusion Criteria

* pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received \>4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count \<200, or any medical or non-medical condition considered by the investigator to preclude participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No