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FMT for Postop Crohn's Disease

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capsule fecal microbiota material (cap-FMT)
Colonoscopic fecal microbiota material (colo-FMT)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Crohn Disease focused on measuring Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Capsule fecal microbiota material (cap-FMT)

Colonoscopic fecal microbiota material (colo-FMT) plus placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ileal-associated microbiota engraftment
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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2022
Last Updated
May 8, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05248191
Brief Title
FMT for Postop Crohn's Disease
Official Title
Fecal Microbiota Transplant for Postoperative Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single blinded randomized controlled trial
Masking
Participant
Masking Description
Placebo capsules are indistinguishable from study FMT capsules.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capsule fecal microbiota material (cap-FMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Colonoscopic fecal microbiota material (colo-FMT) plus placebo
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Capsule fecal microbiota material (cap-FMT)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Colonoscopic fecal microbiota material (colo-FMT)
Intervention Description
Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid.
Primary Outcome Measure Information:
Title
Ileal-associated microbiota engraftment
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Lopez
Phone
612-625-8999
Email
skunkel@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Vaughn, MD, MS
Organizational Affiliation
University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Lopez
Phone
612-625-8999
Email
skunkel@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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FMT for Postop Crohn's Disease

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