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Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

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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

Tracking Information
First Submitted Date  ICMJE June 9, 2016
First Posted Date  ICMJE June 16, 2016
Last Update Posted Date March 13, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
  • 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.
  • Adverse Events [ Time Frame: 56 days ]
    Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02801656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
  • 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.
  • 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.
  • 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.
  • Efficacy: Health status questionnaire [ Time Frame: 56 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
Official Title  ICMJE Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile
Intervention  ICMJE
  • Biological: Fecal Microbiota Transplantation
    Oral, encapsulated FMT
    Other Name: Stool Transplant
  • 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
  • Drug: Vancomycin Placebo
    Matching placebo to Vancomycin
    Other Name: Vancocin Placebo
Study Arms  ICMJE
  • Experimental: Fecal Microbiota Transplantation
    Oral, encapsulated fecal microbiota transplantation
    Interventions:
    • Biological: Fecal Microbiota Transplantation
    • Drug: Vancomycin Placebo
  • Active Comparator: Vancomycin
    125 mg po qid x 10 days
    Interventions:
    • Drug: Vancomycin
    • Biological: Fecal Microbiota Transplantation Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2016)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Daley, MD FRCPC 7097772089 pkd336@mun.ca
Contact: Carla Penney, BSc ccp204@mun.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801656
Other Study ID Numbers  ICMJE MUN-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After analysis is completed, data will be released
Responsible Party Peter Daley, Memorial University of Newfoundland
Study Sponsor  ICMJE Memorial University of Newfoundland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Daley, MD FRCPC Memorial University
PRS Account Memorial University of Newfoundland
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP