Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801656
Recruitment Status : Not yet recruiting
First Posted : June 16, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Daley, Memorial University of Newfoundland

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Biological: Fecal Microbiota Transplantation Drug: Vancomycin Biological: Fecal Microbiota Transplantation Placebo Drug: Vancomycin Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
Oral, encapsulated fecal microbiota transplantation
Biological: Fecal Microbiota Transplantation
Oral, encapsulated FMT
Other Name: Stool Transplant

Drug: Vancomycin Placebo
Matching placebo to Vancomycin
Other Name: Vancocin Placebo

Active Comparator: Vancomycin
125 mg po qid x 10 days
Drug: Vancomycin
Vancomycin po 125 mg qid x 10 days
Other Name: Vancocin

Biological: Fecal Microbiota Transplantation Placebo
Matching placebo to FMT
Other Name: Stool Transplant Placebo




Primary Outcome Measures :
  1. Efficacy: Cure of diarrhea without recurrence in intention to treat population [ Time Frame: 56 days ]
    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.

  2. Adverse Events [ Time Frame: 56 days ]
    Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.


Secondary Outcome Measures :
  1. Efficacy: Cure of diarrhea without recurrence in a per protocol population [ Time Frame: 56 days ]
    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.

  2. Efficacy: cure of diarrhea in intention to treat and per protocol populations [ Time Frame: 10 days ]
    Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.

  3. Efficacy: time to cure of diarrhea [ Time Frame: 56 days ]
    Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.

  4. Efficacy: Health status questionnaire [ Time Frame: 56 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801656


Contacts
Layout table for location contacts
Contact: Peter Daley, MD FRCPC 7097772089 pkd336@mun.ca
Contact: Carla Penney, BSc ccp204@mun.ca

Locations
Layout table for location information
Canada, Newfoundland and Labrador
Health Sciences Centre Not yet recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Peter Daley, MD FRCPC    7097772089    pkd336@mun.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
Layout table for investigator information
Principal Investigator: Peter Daley, MD FRCPC Memorial University

Layout table for additonal information
Responsible Party: Peter Daley, Assistant Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT02801656     History of Changes
Other Study ID Numbers: MUN-02
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After analysis is completed, data will be released

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents