FMT for Postop Crohn's Disease

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05248191
Collaborator
(none)
30
1
2
21.4
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Capsule fecal microbiota material (cap-FMT)
  • Biological: Colonoscopic fecal microbiota material (colo-FMT)
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single blinded randomized controlled trialSingle blinded randomized controlled trial
Masking:
Single (Participant)
Masking Description:
Placebo capsules are indistinguishable from study FMT capsules.
Primary Purpose:
Basic Science
Official Title:
Fecal Microbiota Transplant for Postoperative Crohn's Disease
Actual Study Start Date :
Apr 20, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Ileal-associated microbiota engraftment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Byron Vaughn, MD, MS, University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05248191
Other Study ID Numbers:
  • GI-2022-30546
First Posted:
Feb 21, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022