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FMT for Postop Crohn's Disease

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ClinicalTrials.gov Identifier: NCT05248191
Recruitment Status : Recruiting
First Posted : February 21, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 9, 2022
First Posted Date  ICMJE February 21, 2022
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE April 20, 2022
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2022)
Ileal-associated microbiota engraftment [ Time Frame: 8 weeks ]
Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.
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 for Postop Crohn's Disease
Official Title  ICMJE Fecal Microbiota Transplant for Postoperative Crohn's Disease
Brief Summary

People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.

This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.

Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single blinded randomized controlled trial
Masking: Single (Participant)
Masking Description:
Placebo capsules are indistinguishable from study FMT capsules.
Primary Purpose: Basic Science
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Biological: Capsule fecal microbiota material (cap-FMT)
    Cap-FMT consists of Lyophilized FMT administered at 5 x 10^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10^12 bacteria.
  • Biological: Colonoscopic fecal microbiota material (colo-FMT)
    Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid.
Study Arms  ICMJE
  • Experimental: Capsule fecal microbiota material (cap-FMT)
    Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly.
    Intervention: Biological: Capsule fecal microbiota material (cap-FMT)
  • Active Comparator: Colonoscopic fecal microbiota material (colo-FMT) plus placebo
    Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly.
    Intervention: Biological: Colonoscopic fecal microbiota material (colo-FMT)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to sign informed consent form
  • Age 18 or older
  • English speaking
  • Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
  • Prior ileocecal resection for CD
  • Stable medications for 30 days
  • Women of reproductive age: Agree to remain abstinent or use effective birth control
  • Able and willing to comply with all study procedures

Exclusion Criteria:

  • Antibiotic therapy within 15 days
  • Probiotic therapy within 15 days
  • Adenomatous polyps that have not been removed
  • Anticipated antibiotic use over the study period
  • Subtotal or total colectomy
  • Current ostomy (ileostomy or colonoscopy)
  • Anticipated surgical procedure over study period
  • Pregnancy
  • Severe food allergy
  • Diagnosis of end stage liver disease or cirrhosis
  • Absolute neutrophil count < 500 cell / uL
  • Life expectancy < 6 months
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: Sharon Lopez 612-625-8999 skunkel@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05248191
Other Study ID Numbers  ICMJE GI-2022-30546
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Byron Vaughn, MD, MS University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
PRS Account University of Minnesota
Verification Date April 2022

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