Status:
COMPLETED
FMT for Postop Crohn's Disease
Lead Sponsor:
University of Minnesota
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 mi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05248191
Start Date
April 20 2022
End Date
May 16 2024
Last Update
December 17 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455