Crohn Disease
Conditions
Keywords
Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant
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.
Interventions
BIOLOGICALCapsule 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.
BIOLOGICALColonoscopic 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Placebo capsules are indistinguishable from study FMT capsules.
Intervention model description
Single blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed