Using fecal microbiota transplantation to treat uncomplicated diverticulitis

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

This study is testing whether a treatment using healthy stool from donors can help people with uncomplicated diverticulitis feel better and improve their gut health.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Massachusetts, Worcester (Academic / other)
• Locations: 1 site (Worcester, Massachusetts)
• Trial ID: NCT05373784 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of fecal microbiota transplantation (FMT) for patients with uncomplicated diverticulitis. FMT will be administered via colonoscopy using donor stool samples that have undergone FDA testing. Participants will be monitored for adverse events post-procedure and will have follow-up visits to assess their health and microbiome changes over the course of one year. The study aims to provide insights into the feasibility of using FMT as a treatment option for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a history of uncomplicated diverticulitis who are eligible for surgical resection.

Not a fit: Patients with active diverticulitis flare or complicated diverticulitis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option for patients suffering from uncomplicated diverticulitis, potentially reducing reliance on antibiotics and surgical interventions.

How similar studies have performed: While FMT has shown success in treating C. difficile infections, its application in diverticulitis is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Worcester, Massachusetts

• UMASS Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Justin A Maykel, MD — UMass Chan Medical School
• Study coordinator: Justin A Maykel, MD

Conditions Diverticulitis; Uncomplicated Diverticular Disease