10 Participants Needed

Fecal Microbiota Transplantation for Diverticulitis

JA
CC
AM
BG
Overseen ByBenjamin Gallant, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Justin Maykel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test if FMT, which uses healthy donor stool to restore gut bacteria, can help patients with uncomplicated diverticulitis who have few other treatment options. FMT is commonly used to treat Clostridium difficile infection and is being explored for other conditions like inflammatory bowel disease.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used antibiotics in the last 90 days, you may not be eligible to participate.

Is fecal microbiota transplantation (FMT) safe for humans?

FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. However, serious adverse events have been associated with FMT products from stool banks that do not screen for multi-drug resistant organisms, so strict donor screening is important.12345

How is fecal microbiota transplantation (FMT) different from other treatments for diverticulitis?

Fecal microbiota transplantation (FMT) is unique because it involves transferring healthy bacteria from a donor's stool to restore balance in the gut microbiome, which is thought to be disrupted in diverticulitis. Unlike traditional treatments that may focus on antibiotics or surgery, FMT aims to address the underlying gut bacteria imbalance, offering a novel approach for managing this condition.23678

What data supports the effectiveness of the treatment Fecal Microbiota Transplantation (FMT) for diverticulitis?

FMT is known to be effective for treating recurrent Clostridium difficile infections, and there is potential for it to help with other conditions like inflammatory bowel disease. Although there are no studies specifically on FMT for diverticulitis, it is considered a safe way to restore healthy gut bacteria, which might help with conditions involving gut bacteria imbalance.236910

Who Is on the Research Team?

JA

Justin A Maykel, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had at least one episode of uncomplicated diverticulitis, confirmed by imaging and symptoms. It's aimed at those eligible for surgical resection but are exploring other options.

Inclusion Criteria

Donor: Able to provide informed consent
I have had at least one episode of diverticulitis confirmed by tests.
I am eligible for surgery to remove my cancer.
See 1 more

Exclusion Criteria

I am at high risk for infections that don't respond to standard antibiotics.
I have a history of gastrointestinal issues.
I use natural family planning methods only and am sexually active.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Fecal Microbiota Transplantation (FMT) via colonoscopy using donor stool

1 day
1 visit (in-person)

Initial Follow-up

Participants are monitored for adverse events and baseline health post-FMT

2 weeks
Phone calls at 24 hours and 2 weeks post-procedure

Extended Follow-up

Participants are monitored for safety and effectiveness with follow-up visits and stool sample collection

1 year
In-person visits at 1 month, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Fecal Microbiota Transplantation (FMT)
Trial Overview The study tests Fecal Microbiota Transplantation (FMT) as a treatment for diverticulitis. The goal is to see if transferring healthy gut bacteria into patients can improve their condition without surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: FMT cohortExperimental Treatment1 Intervention

Fecal Microbiota Transplantation (FMT) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Fecal Microbiota Transplantation for:
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Approved in United States as Fecal Microbiota Transplantation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Justin Maykel

Lead Sponsor

Trials
1
Recruited
10+

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) was successfully used to treat a 63-year-old woman with a long history of recurrent diverticulitis and Clostridium difficile infection, leading to no further recurrences over 20 months of follow-up.
This case suggests that FMT may be a promising new treatment option for patients with refractory diverticulitis, although more research is needed to confirm its efficacy and safety in larger populations.
Resolution of multiply recurrent and multifocal diverticulitis after fecal microbiota transplantation.Meyer, DC., Hill, SS., Bebinger, DM., et al.[2023]
In a review of 12 published studies on fecal microbiota transplantation (FMT) for inflammatory bowel disease (IBD), only one study suggested a significant donor effect, while the majority showed no statistically significant differences in efficacy based on donor material.
Despite the lack of strong evidence for donor effects, the study highlights that the existing data cannot completely rule out their potential clinical importance, indicating a need for larger, well-designed trials to explore this further.
Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease.Olesen, SW., Gerardin, Y.[2021]
Fecal microbiota transplantation (FMT) has a total adverse event (AE) incidence rate of 28.5%, with abdominal discomfort being the most common AE reported in 19 studies, highlighting the need for careful monitoring during the procedure.
Serious adverse events (SAEs) occurred in 9.2% of patients, with a notable incidence of death (3.5%) and infections (2.5%), indicating that while FMT can be beneficial, it carries significant risks that require further investigation through high-quality randomized controlled trials.
Systematic Review: Adverse Events of Fecal Microbiota Transplantation.Wang, S., Xu, M., Wang, W., et al.[2023]

Citations

Resolution of multiply recurrent and multifocal diverticulitis after fecal microbiota transplantation. [2023]
Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease. [2021]
Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]
Faecal microbiota transplantation: establishment of a clinical application framework. [2022]
Fecal Transplantation for Treatment of Clostridium Difficile Infection in Elderly and Debilitated Patients. [2020]
Efficacy and safety of fecal microbiota transplant in irritable bowel syndrome: An update based on meta-analysis of randomized control trials. [2022]
Fecal Microbiota Transplantation: Is It Safe? [2021]
Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020. [2021]
A systematic review of economic evaluation in fecal microbiota transplantation. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Clinical Application and Potential of Fecal Microbiota Transplantation. [2022]
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