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DiverticulitisEarly Phase 1NCT05373784

FMT in Uncomplicated Diverticulitis

A Early Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Diverticulitis and Uncomplicated Diverticular Disease, run by Justin Maykel at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Fecal Microbiota Transplantation (FMT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
15 Mar 2024to 30 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Recipient Inclusion Criteria:

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

Recipient Exclusion Criteria:

  1. Subjects <18 years of age
  2. Patients with active diverticulitis flare
  3. Evidence of complicated diverticulitis (diverticulitis with abscess/phlegmon, bleeding, stricture, fistula or perforation) on imaging
  4. Prior fecal transplant
  5. Patients unable to provide informed consent
  6. Pregnant and/or breastfeeding women
  7. Prisoners
  8. Students
  9. Prior small or large bowel obstruction within the past year
  10. Prior major gastrointestinal or intra-abdominal surgery
  11. Any major illness or condition that may substantially increase risks to the recipient based on the investigator's judgment.
  12. Sexually active women who adhere to natural family planning alone

Donor Inclusion Criteria:

  1. Adult patients ≥18 years old
  2. 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."
  3. Able to provide informed consent

Donor Exclusion Criteria:

  1. History of diverticulitis
  2. Recent COVID-19 infection, confirmed or suspected exposure to COVD-19 within the past eight weeks. Such subjects will be excluded irrespective of negative COVID nasopharyngeal test.
  3. Risk of infectious agent
  • Known exposure to HIV, syphilis, or viral hepatitis (within the previous 12 months)
  • High-risk sexual behaviors including sexual contact with anyone with HIV/AIDS or hepatitis, men who have sex with men, sex for drugs or money
  • Use of illicit intravenous (IV) drug use
  • Tattoo or body piercing within 6 months
  • Incarceration within previous 12 months
  • Known current communicable disease (e.g., COVID 19, Influenza, STDs, HIV/AIDS, Hepatitis B and C)
  • Risk factors for variant Creutzfeldt-Jacob disease to prevent potential transmission of abnormal/pathologic prions (cellular proteins), which are the basis of this disease.
  • Receipt of blood transfusion from country other than the United States of America (USA) and Canada in the previous 6 months
  1. Individuals who are at a higher risk for colonization with multi-drug resistant organisms (MDRO):
  • Health care workers
  • Persons who have been hospitalized or discharged from long-term care facilities in the past 30 days
  • Persons who regularly attend outpatient medical or surgical clinics
  • Persons who have engaged in medical tourism in the past 30 days
  1. Gastrointestinal comorbidities
  • History of inflammatory bowel disease
  • History of celiac disease
  • History of irritable bowel syndrome, idiopathic chronic constipation, or chronic diarrhea
  • History of gastrointestinal malignancy
  1. Other
  • Antibiotic use within the preceding 90 days
  • Ingestion of a potential allergen (e.g., nuts) where recipient has a known allergy to this agent within the past 30 days
  • Systemic autoimmunity (e.g., multiple sclerosis, connective tissue disease)
  • Chronic pain syndromes (e.g., chronic fatigue syndrome, fibromyalgia)
  • Fever, defined as temperature of 100 F or 38.7C, on the day of stool donation. Potential donors will be allowed to re-screen within 1 week if febrile on the day of stool donation. .
  • Sexually active women who adhere to natural family planning alone as method of contraception
  • Prisoners
  • Students
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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.

Read the detailed description

This study aims to assess the safety and efficacy of fecal microbiota transplantation (FMT) in treating uncomplicated diverticulitis. FMT will be delivered via colonoscopy using donor stool. Fecal material samples obtained from the University of Minnesota Microbiota Therapeutics Program (UMMTP) will be used each patients FMT. These samples undergo FDA mandated testing prior to being used as donor samples.

Recipients will undergo FMT via Colonoscopy at UMASS Memorial Medical Center and will be monitored for one hour after the procedure to ensure they are not experiencing any adverse events. They will receive a phone call 24 hours and 2 weeks after their procedure to ensure that they are at their baseline health. Recipients follow-up visits will occur at one month, 3 month, 6 months and 1 year post FMT.

Baseline stool samples will be collected from both the recipients and the UMMTP samples for baseline metagenomic sequencing. Recipient stool samples will be obtained weekly for the first month, then at 3 months, 6 months and 1 year. Microbiome analyses will also performed on recipient all stool samples post FMT to assess for successful engraftment of donor's microbiota onto the recipient's.

Being tested
Fecal Microbiota Transplantation (FMT)
Medical subject headings
Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05373784
Study groupRoleWhat they receive
FMT cohortExperimentalThis will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.
Receives: Biological: Fecal Microbiota Transplantation (FMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. Necessity for surgery

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start15 Mar 2024
  3. Primary completion20 Feb 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This will be a pilot study of 10 patients with a diagnosis of uncomplicated diverticulitis who will undergo FMT.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05373784
Sponsor's protocol ID
STUDY00000055
Status last verified
May 2026
First submitted
9 May 2022
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fecal Microbiota Transplantation (FMT) in people with Diverticulitis and Uncomplicated Diverticular Disease, run by Justin Maykel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of diverticular flares/attacks since FMT (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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