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.
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
- Conditions the study is for
- Diverticulitis, Uncomplicated Diverticular Disease
- 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:
- Age >18
- One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms.
- Eligible for surgical resection
Recipient Exclusion Criteria:
- Subjects <18 years of age
- Patients with active diverticulitis flare
- Evidence of complicated diverticulitis (diverticulitis with abscess/phlegmon, bleeding, stricture, fistula or perforation) on imaging
- Prior fecal transplant
- Patients unable to provide informed consent
- Pregnant and/or breastfeeding women
- Prisoners
- Students
- Prior small or large bowel obstruction within the past year
- Prior major gastrointestinal or intra-abdominal surgery
- Any major illness or condition that may substantially increase risks to the recipient based on the investigator's judgment.
- Sexually active women who adhere to natural family planning alone
Donor Inclusion Criteria:
- Adult patients ≥18 years old
- 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."
- Able to provide informed consent
Donor Exclusion Criteria:
- History of diverticulitis
- 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.
- 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
- 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
- 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
- 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
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.
- Conditions
- Diverticulitis, Uncomplicated Diverticular Disease
- 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 group | Role | What they receive |
|---|---|---|
| FMT cohort | Experimental | This 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.
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
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
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
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.
- First posted13 May 2022
- Study start15 Mar 2024
- Primary completion20 Feb 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Justin Maykel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Justin Maykel, University of Massachusetts, Worcester
- Investigators
- Justin A Maykel, MD, Principal investigator, UMass Chan Medical School
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Fecal Microbiota Transplantation (FMT) in Uncomplicated Diverticulitis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05373784
- Acronym / sponsor ID
- STUDY00000055
- Conditions
- Diverticulitis, Uncomplicated Diverticular Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Justin MaykelUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a pilot study of 10 patients with a diagnosis of uncomplicated diverticulitis who will undergo FMT.
| Arm | Type | Receives |
|---|---|---|
| FMT cohort | Experimental | Biological: Fecal Microbiota Transplantation (FMT)This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | FMT cohort |
Primary outcome
Number of diverticular flares/attacks since FMT
Time frame: 1 year
After FMT, recipients/participants will be asked to report the number of diverticulitis episodes they have experienced since FMT
Number of emergency room visits and hospitalizations due to diverticulitis since FMT
Time frame: 1 year
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.
Number of courses of antibiotics required for the treatment of diverticulitis since FMT
Time frame: 1 year
After FMT, recipients/participants will be asked to report whether they required any antibiotics due to diverticulitis
Necessity for surgery
Time frame: 1 year
After FMT, recipients/participants will be asked to report whether they required surgery to treat diverticulitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Diverticulitis
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
Not yet recruitingObservational study
Differentiating Right-sided Epiploic Appendagitis From Diverticulitis
Epiploic Appendagitis
Enrolling by invitationObservational study
Shortwave Infrared Surgical Imaging Device Study
Cholecystitis, Cholecystitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin A Maykel, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
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.