Fecal Microbiota Transplantation (FMT) for Diverticulitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UMASS Memorial Medical Center, Worcester, MA
Diverticulitis+5 More
Fecal Microbiota Transplantation (FMT) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Diverticulitis
  • Uncomplicated Diverticular Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Necessity for surgery
Number of courses of antibiotics required for the treatment of diverticulitis since FMT
Number of diverticular flares/attacks since FMT
Number of emergency room visits and hospitalizations due to diverticulitis since FMT

Trial Safety

Side Effects for

Fecal Microbiota Transplantation
48%Abdominal Pain
22%Flatulence and bloating
22%Diarrhea
13%Emesis
9%Bloody stools
9%Nausea
4%Fever
This histogram enumerates side effects from a completed 2016 Phase 1 trial (NCT02108821) in the Fecal Microbiota Transplantation ARM group. Side effects include: Abdominal Pain with 48%, Flatulence and bloating with 22%, Diarrhea with 22%, Emesis with 13%, Bloody stools with 9%.

Trial Design

1 Treatment Group

FMT cohort
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Fecal Microbiota Transplantation (FMT) · No Placebo Group · Phase < 1

FMT cohort
Biological
Experimental Group · 1 Intervention: Fecal Microbiota Transplantation (FMT) · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: UMASS Memorial Medical Center · Worcester, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
2017First Recorded Clinical Trial
1 TrialsResearching Diverticulitis
18 CompletedClinical Trials

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
306 Previous Clinical Trials
741,119 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had at least one episode of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.