Status:
ACTIVE_NOT_RECRUITING
FMT in Uncomplicated Diverticulitis
Lead Sponsor:
Justin Maykel
Conditions:
Diverticulitis
Uncomplicated Diverticular Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significan...
Detailed Description
This study aims to assess the safety and efficacy of fecal microbiota transplantation (FMT) in treating uncomplicated diverticulitis. FMT will be delivered via colonoscopy using donor stool. Fecal mat...
Eligibility Criteria
Inclusion
- Recipient
- Age \>18
- One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms.
- Eligible for surgical resection
- Recipient
Exclusion
- Subjects \<18 years of age
- Patients with active diverticulitis flare
- Evidence of complicated diverticulitis (diverticulitis with abscess/phlegmon, bleeding, stricture, fistula or perforation) on imaging
- Prior fecal transplant
- Patients unable to provide informed consent
- Pregnant and/or breastfeeding women
- Prisoners
- Students
- Prior small or large bowel obstruction within the past year
- Prior major gastrointestinal or intra-abdominal surgery
- Any major illness or condition that may substantially increase risks to the recipient based on the investigator's judgment.
- Sexually active women who adhere to natural family planning alone
- Donor Inclusion Criteria:
- Adult patients ≥18 years old
- Colonoscopy screening as recommended by the American Cancer Society. However, it is to be noted that only recipients will undergo colonoscopy for receipt of FMT as part of the study, not donors. We will only ensure that the prospective donor follows the recommended guidelines for screening colonoscopy, which are to begin at the age of 45. If the donor does not meet such guidelines, s/he will not be allowed to proceed as a donor. If a donor is not yet eligible to undergo screening colonoscopy (i.e., younger than 45), this will not be required of him/her."
- Able to provide informed consent
- Donor
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05373784
Start Date
March 15 2024
End Date
May 30 2026
Last Update
June 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01605