FMT in Uncomplicated Diverticulitis

NCT05373784 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00000055
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome among affected patients who have failed other treatments. Diverticulitis is a major, and often recurrent, source of morbidity in the U.S for which antibiotics and surgical resection constitute the only treatment options to date. Although alterations of the intestinal microbiome have also been shown among patients with diverticular disease, research on FMT in diverticulitis is sparse. The intended goal of this project is to determine the feasibility, effectiveness and safety of FMT in the treatment of uncomplicated diverticulitis, using clinical outcomes and microbiome analyses.

Conditions

Diverticulitis; Uncomplicated Diverticular Disease

Outcome Measures

Primary Outcomes (4)

• Number of diverticular flares/attacks since FMT

  After FMT, recipients/participants will be asked to report the number of diverticulitis episodes they have experienced since FMT

  1 year

• Number of emergency room visits and hospitalizations due to diverticulitis since FMT

  After FMT, recipients/participants will be asked to report the number of times (if any) they presented to the emergency room or were hospitalized due to diverticulitis.

  1 year

• Number of courses of antibiotics required for the treatment of diverticulitis since FMT

  After FMT, recipients/participants will be asked to report whether they required any antibiotics due to diverticulitis

  1 year

• Necessity for surgery

  After FMT, recipients/participants will be asked to report whether they required surgery to treat diverticulitis

  1 year

Study Arms (1)

FMT cohort

EXPERIMENTAL

This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of another individual. This is currently an accepted method of treatment for recurrent colitis secondary to Clostridium difficile infection refractory to antibiotics/medical management. FMT can be delivered via capsule endoscopy or via colonoscopy. In this study, it will be administered via colonoscopy.

FMT cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms.
• Eligible for surgical resection

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Justin Maykel: lead

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Diverticulitis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Justin A Maykel, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: This will be a pilot study of 10 patients with a diagnosis of uncomplicated diverticulitis who will undergo FMT.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: March 15, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)