Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

NCT02801656 | Withdrawn Phase 3

• 1 other identifier: MUN-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (2)

• 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.

  56 days

• Adverse Events

  Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.

  56 days

Secondary Outcomes (4)

• Efficacy: Cure of diarrhea without recurrence in a per protocol population

  56 days

• Efficacy: cure of diarrhea in intention to treat and per protocol populations

  10 days

• Efficacy: time to cure of diarrhea

  56 days

• Efficacy: Health status questionnaire

  56 days

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL

Oral, encapsulated fecal microbiota transplantation

Biological: Fecal Microbiota Transplantation; Drug: Vancomycin Placebo

Vancomycin

ACTIVE COMPARATOR

125 mg po qid x 10 days

Drug: Vancomycin; Biological: Fecal Microbiota Transplantation Placebo

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Oral, encapsulated FMT

Also known as: Stool Transplant

Fecal Microbiota Transplantation

Vancomycin DRUG

Vancomycin po 125 mg qid x 10 days

Also known as: Vancocin

Vancomycin

Fecal Microbiota Transplantation Placebo BIOLOGICAL

Matching placebo to FMT

Also known as: Stool Transplant Placebo

Vancomycin

Vancomycin Placebo DRUG

Matching placebo to Vancomycin

Also known as: Vancocin Placebo

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Vancomycin

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Daley, MD FRCPC

  Memorial University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: December 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)