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FMT for Postop Crohn's Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Crohn Disease Biological: Capsule fecal microbiota material (cap-FMT) Biological: Colonoscopic fecal microbiota material (colo-FMT) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Fecal Microbiota Transplant for Postoperative Crohn's Disease
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05248191


Contacts
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Contact: Sharon Lopez 612-625-8999 skunkel@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sharon Lopez    612-625-8999    skunkel@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Byron Vaughn, MD, MS University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05248191    
Other Study ID Numbers: GI-2022-30546
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Crohn's disease
Ileocecal resection
Fecal microbiota transplant
Intestinal microbiota transplant
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases