FMT in Uncomplicated Diverticulitis
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|ClinicalTrials.gov Identifier: NCT05373784|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : December 6, 2023
|Condition or disease||Intervention/treatment||Phase|
|Diverticulitis Uncomplicated Diverticular Disease||Biological: Fecal Microbiota Transplantation (FMT)||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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)|
|Official Title:||Outcomes of Fecal Microbiota Transplantation (FMT) in Uncomplicated Diverticulitis: A Pilot Study|
|Estimated Study Start Date :||December 30, 2023|
|Estimated Primary Completion Date :||August 15, 2024|
|Estimated Study Completion Date :||December 30, 2024|
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.
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05373784
|Contact: Justin A Maykel, MDemail@example.com|
|Contact: Alexandra M Onyiego, MDfirstname.lastname@example.org|
|Principal Investigator:||Justin A Maykel, MD||UMass Chan Medical School|