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Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Primary Purpose

Clostridium Difficile

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Vancomycin
Fecal Microbiota Transplantation Placebo
Vancomycin Placebo
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fecal Microbiota Transplantation

Vancomycin

Arm Description

Oral, encapsulated fecal microbiota transplantation

125 mg po qid x 10 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Efficacy: Health status questionnaire

Full Information

First Posted
June 9, 2016
Last Updated
April 22, 2022
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT02801656
Brief Title
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
Official Title
Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not funded
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal Microbiota Transplantation
Arm Type
Experimental
Arm Description
Oral, encapsulated fecal microbiota transplantation
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
125 mg po qid x 10 days
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Stool Transplant
Intervention Description
Oral, encapsulated FMT
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
Vancomycin po 125 mg qid x 10 days
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation Placebo
Other Intervention Name(s)
Stool Transplant Placebo
Intervention Description
Matching placebo to FMT
Intervention Type
Drug
Intervention Name(s)
Vancomycin Placebo
Other Intervention Name(s)
Vancocin Placebo
Intervention Description
Matching placebo to Vancomycin
Primary Outcome Measure Information:
Title
Efficacy: Cure of diarrhea without recurrence in intention to treat population
Description
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
Title
Adverse Events
Description
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Efficacy: Cure of diarrhea without recurrence in a per protocol population
Description
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
Title
Efficacy: cure of diarrhea in intention to treat and per protocol populations
Description
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
Title
Efficacy: time to cure of diarrhea
Description
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
Title
Efficacy: Health status questionnaire
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Daley, MD FRCPC
Organizational Affiliation
Memorial University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After analysis is completed, data will be released

Learn more about this trial

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

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