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FMT in Uncomplicated Diverticulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05373784
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
Justin Maykel, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE May 9, 2022
First Posted Date  ICMJE May 13, 2022
Last Update Posted Date December 6, 2023
Estimated Study Start Date  ICMJE December 30, 2023
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FMT in Uncomplicated Diverticulitis
Official Title  ICMJE Outcomes of Fecal Microbiota Transplantation (FMT) in Uncomplicated Diverticulitis: A Pilot Study
Brief 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 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. Upon enrollment, patients or intended recipients will be asked to identify a potential donor. Donors will undergo a series of serologic, stool and COVID-19 testing to ensure that they meet inclusion and exclusion criteria prior to stool donation.

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 donors and recipients 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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Diverticulitis
  • Uncomplicated Diverticular Disease
Intervention  ICMJE Biological: 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.
Study Arms  ICMJE Experimental: FMT cohort
This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.
Intervention: Biological: Fecal Microbiota Transplantation (FMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2022)		 10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2024
Estimated Primary Completion Date August 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Justin A Maykel, MD 508-334-8195 justin.maykel@umassmemorial.org
Contact: Alexandra M Onyiego, MD 508-334-8195 alexandra.onyiego@umassmemorial.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05373784
Other Study ID Numbers  ICMJE STUDY00000055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Justin Maykel, University of Massachusetts, Worcester
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Justin Maykel
Original Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Justin A Maykel, MD UMass Chan Medical School
PRS Account University of Massachusetts, Worcester
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP