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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single blinded randomized controlled trial|
|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|
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.
- 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.
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
|Contact: Sharon Lopezemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Sharon Lopez 612-625-8999 firstname.lastname@example.org|
|Principal Investigator:||Byron Vaughn, MD, MS||University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition|