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FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02254811
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 24, 2019
University of Calgary
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE September 18, 2014
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
Proportion of patients without recurrent CDI [ Time Frame: 12 weeks after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
Official Title  ICMJE A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)
Brief Summary Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.
Detailed Description Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1 mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical cost for previous treatment is collected as well at pt perspective and QoL.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Enterocolitis Clostridium Difficile Recurrent
Intervention  ICMJE Biological: Fecal Microbiota Transplant
transfer of healthy human gut bacteria to restore the microbiome
Study Arms  ICMJE
  • Experimental: Delivery via capsule
    Fecal microbiota transplant is delivered by oral capsules
    Intervention: Biological: Fecal Microbiota Transplant
  • Experimental: Delivery via colonoscopy
    Fecal microbiota transplant delivered by colonoscopy
    Intervention: Biological: Fecal Microbiota Transplant
Publications * Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, Madsen K, Mason A, Wong GK, Jovel J, Patterson J, Louie T. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2014)
Actual Study Completion Date  ICMJE September 13, 2017
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > 18 and < 90 years at the time of Screening.
  2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other.
  3. CDI infection under symptomatic control with < 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
  4. Those with ability to provide informed consent.

Exclusion Criteria:

  1. Those with complicated CDI, defined as white blood cell>35 or <0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure < 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission.
  2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02254811
Other Study ID Numbers  ICMJE 48233
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dina Kao, University of Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Calgary
Investigators  ICMJE
Principal Investigator: Dina Kao, MD University of Alberta
PRS Account University of Alberta
Verification Date October 2019

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