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Microbiome Restoration

Fecal Microbiota Transplantation for Diverticulitis

Phase < 1
Recruiting
Led By Justin A Maykel, MD
Research Sponsored by Justin Maykel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recipient: One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms
Recipient: Eligible for surgical resection
Must not have
Donor: Gastrointestinal comorbidities
Recipient: Subjects <18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial will test whether fecal microbiota transplantation (FMT) is a safe and effective treatment for people with diverticulitis that has not responded to other treatments.

Who is the study for?
This trial is for adults over 18 who have had at least one episode of uncomplicated diverticulitis, confirmed by imaging and symptoms. It's aimed at those eligible for surgical resection but are exploring other options.Check my eligibility
What is being tested?
The study tests Fecal Microbiota Transplantation (FMT) as a treatment for diverticulitis. The goal is to see if transferring healthy gut bacteria into patients can improve their condition without surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort or infection at the transplant site, changes in bowel habits, abdominal pain, and possible allergic reactions to the transplanted material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one episode of diverticulitis confirmed by tests.
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I am eligible for surgery to remove my cancer.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of gastrointestinal issues.
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I am under 18 years old.
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I have had major surgery in my stomach or abdomen area before.
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I have a history of diverticulitis.
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I have had a blockage in my intestines within the last year.
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I am unable to give informed consent by myself.
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I am currently experiencing a flare-up of diverticulitis.
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I have had a fecal transplant before.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Necessity for surgery
Number of courses of antibiotics required for the treatment of diverticulitis since FMT
Number of diverticular flares/attacks since FMT
+1 more

Side effects data

From 2016 Phase 1 trial • 23 Patients • NCT02108821
48%
Abdominal Pain
22%
Flatulence and bloating
22%
Diarrhea
13%
Emesis
9%
Bloody stools
9%
Nausea
4%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplantation

Trial Design

1Treatment groups
Experimental Treatment
Group I: FMT cohortExperimental Treatment1 Intervention
This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~170

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Diverticulosis focus on managing symptoms and preventing complications. One emerging treatment is Fecal Microbiota Transplantation (FMT), which aims to restore a healthy gut microbiome by transplanting fecal bacteria from a healthy donor to the patient. This is particularly relevant for Diverticulosis patients as alterations in the gut microbiome are believed to contribute to the condition. By restoring a balanced microbiome, FMT may reduce inflammation and improve gut health, potentially alleviating symptoms and preventing recurrent episodes. Other common treatments include dietary modifications, such as increasing fiber intake, and the use of probiotics to support gut health.

Find a Location

Who is running the clinical trial?

Justin MaykelLead Sponsor
University of Massachusetts, WorcesterLead Sponsor
350 Previous Clinical Trials
989,820 Total Patients Enrolled
Justin A Maykel, MDPrincipal InvestigatorUMass Chan Medical School

Media Library

Fecal Microbiota Transplantation (FMT) (Microbiome Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT05373784 — Phase < 1
Diverticulosis Research Study Groups: FMT cohort
Diverticulosis Clinical Trial 2023: Fecal Microbiota Transplantation (FMT) Highlights & Side Effects. Trial Name: NCT05373784 — Phase < 1
Fecal Microbiota Transplantation (FMT) (Microbiome Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373784 — Phase < 1
~7 spots leftby Mar 2025