Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2022-04-20
2024-05-16
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Byron Vaughn, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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GI-2022-30546
Identifier Type: -
Identifier Source: org_study_id