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Poop pills may tame painful gut Flare-Ups

NCT ID NCT05373784

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether a fecal transplant (FMT) can help people with recurring diverticulitis, a painful gut condition. Ten adults who have had at least one flare will receive donor stool to restore healthy gut bacteria. Researchers will track flares, ER visits, antibiotic use, and need for surgery over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 4. 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 5. 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 6. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01605, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.