FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

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

Tracking Information

• First Submitted Date: September 29, 2014
• First Posted Date: October 2, 2014
• Last Update Posted Date: October 24, 2019
• Actual Study Start Date: September 18, 2014
• Actual Primary Completion Date: December 12, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 1, 2014): Proportion of patients without recurrent CDI [ Time Frame: 12 weeks after treatment ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Enterocolitis Clostridium Difficile Recurrent

Intervention

Biological: Fecal Microbiota Transplant

transfer of healthy human gut bacteria to restore the microbiome

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 2, 2016): 116
• Original Estimated Enrollment (submitted: October 1, 2014): 200
• Actual Study Completion Date: September 13, 2017
• Actual Primary Completion Date: December 12, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02254811
• Other Study ID Numbers: 48233
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dina Kao, University of Alberta
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current
• Collaborators: University of Calgary

Investigators

• Principal Investigator: Dina Kao, MD; University of Alberta

• PRS Account: University of Alberta
• Verification Date: October 2019