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FMT in Uncomplicated Diverticulitis

NCT05373784 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

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.

Sponsors & Collaborators

  • Justin Maykel

    lead OTHER

Principal Investigators

  • Justin A Maykel, MD · UMass Chan Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-02-20
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373784 on ClinicalTrials.gov