ACTIVE_NOT_RECRUITING

FMT in Uncomplicated Diverticulitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Outcomes of Fecal Microbiota Transplantation (FMT) in Uncomplicated Diverticulitis: A Pilot Study

Quick Facts

Study Start:2024-03-15
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05373784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>18
  2. 2. One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms.
  3. 3. Eligible for surgical resection
  1. 1. Subjects \<18 years of age
  2. 2. Patients with active diverticulitis flare
  3. 3. Evidence of complicated diverticulitis (diverticulitis with abscess/phlegmon, bleeding, stricture, fistula or perforation) on imaging
  4. 4. Prior fecal transplant
  5. 5. Patients unable to provide informed consent
  6. 6. Pregnant and/or breastfeeding women
  7. 7. Prisoners
  8. 8. Students
  9. 9. Prior small or large bowel obstruction within the past year
  10. 10. Prior major gastrointestinal or intra-abdominal surgery
  11. 11. Any major illness or condition that may substantially increase risks to the recipient based on the investigator's judgment.
  12. 12. Sexually active women who adhere to natural family planning alone

Contacts and Locations

Principal Investigator

Justin A Maykel, MD
PRINCIPAL_INVESTIGATOR
UMass Chan Medical School

Study Locations (Sites)

UMASS Memorial Medical Center
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: Justin Maykel

  • Justin A Maykel, MD, PRINCIPAL_INVESTIGATOR, UMass Chan Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-15
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2024-03-15
Study Completion Date2026-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diverticulitis
  • Uncomplicated Diverticular Disease