Diverticulitis, Uncomplicated Diverticular Disease
Conditions
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. 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.
Interventions
BIOLOGICALFecal 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.
Sponsors
Justin Maykel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a pilot study of 10 patients with a diagnosis of uncomplicated diverticulitis who will undergo FMT.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of diverticular flares/attacks since FMT | 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 | 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 | 1 year | After FMT, recipients/participants will be asked to report whether they required any antibiotics due to diverticulitis |
| Necessity for surgery | 1 year | After FMT, recipients/participants will be asked to report whether they required surgery to treat diverticulitis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJustin A Maykel, MD
UMass Chan Medical School
Outcome results
None listed