Fecal Microbiota Transplantation for Diverticulitis

Overseen By Benjamin Gallant, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Justin Maykel

Disqualifiers: Active diverticulitis, Complicated diverticulitis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 26

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests fecal microbiota transplantation (FMT), a treatment using stool from a healthy donor, to determine if it alleviates symptoms in people with uncomplicated diverticulitis. Diverticulitis is a painful condition where small pouches in the colon become inflamed, and current treatments mainly involve antibiotics or surgery. Researchers aim to discover if FMT can safely and effectively restore a healthy balance of gut bacteria for those affected. Individuals who have experienced at least one episode of uncomplicated diverticulitis and are eligible for surgery might be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how FMT works in people, offering participants a chance to be among the first to receive this innovative treatment.

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.

What prior data suggests that Fecal Microbiota Transplantation is safe for diverticulitis?

Research has shown that fecal microbiota transplantation (FMT) is generally safe. In studies on repeated C. diff infections, FMT effectively restores healthy gut bacteria, helping to control infections and prevent recurrence.

Evidence from several well-designed studies and a large group of cases also supports FMT's safety. A detailed review of these studies confirmed its safety and effectiveness for various conditions. While FMT is commonly used for C. diff, its use in diverticulitis remains under study. However, its proven safety in other conditions may reassure those considering joining a trial for diverticulitis.

In summary, FMT has a strong safety record in treating other gut-related issues, suggesting it might be well-tolerated for diverticulitis as well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fecal Microbiota Transplantation (FMT) is unique because it introduces a new way of managing diverticulitis by using beneficial bacteria from healthy donors. Unlike traditional treatments, which often include antibiotics and dietary changes, FMT aims to restore a balanced gut microbiome, potentially addressing the root cause of inflammation rather than just managing symptoms. Researchers are excited about FMT because it offers a more natural approach that could lead to fewer recurrences and a healthier gut environment overall.

What evidence suggests that Fecal Microbiota Transplantation might be an effective treatment for diverticulitis?

Studies have shown that Fecal Microbiota Transplantation (FMT) effectively treats Clostridium difficile (C. diff) infections by restoring a healthy balance of gut bacteria. Research suggests that altering gut bacteria can aid various conditions, including diverticulitis. Although direct evidence for FMT's effectiveness in treating diverticulitis remains limited, its success with other gut issues suggests potential benefits. This trial will explore FMT's ability to improve gut health and manage diverticulitis in participants. Early signs indicate that FMT could benefit this condition. ^{2 4 5 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: FMT cohort Experimental Treatment 1 Intervention

This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.

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:

• Recurrent Clostridium difficile infection

Approved in United States as Fecal Microbiota Transplantation for:

• Recurrent Clostridium difficile infection

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

Faecal microbiota transplantation (FMT) is being established as a safe second-line treatment for recurrent Clostridium difficile infections, with a comprehensive framework developed to ensure donor screening and clinical application comply with the European Tissue Act.

The framework includes rigorous donor recruitment and screening processes, laboratory protocols for processing faecal samples, and a structured follow-up system to monitor patient outcomes, ensuring safety and traceability in FMT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. Jørgensen, SMD., Hansen, MM., Erikstrup, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of multiply recurrent and multifocal diverticulitis after fecal microbiota transplantation. Meyer, DC., Hill, SS., Bebinger, DM., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. Wang, S., Xu, M., Wang, W., et al.[2023]

Fecal microbiota transplantation (FMT) showed a high efficacy rate in elderly patients with recurrent Clostridium difficile infection, with 90% of FMT patients improving within 3 days compared to only 39% in the conventional treatment group.

While FMT is effective, there are safety concerns, as two patients experienced significant adverse events during the procedure, suggesting that colonoscopy may be the safer method for administering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Transplantation for Treatment of Clostridium Difficile Infection in Elderly and Debilitated Patients. Friedman-Korn, T., Livovsky, DM., Maharshak, N., et al.[2020]

A systematic review of 129 studies involving 4241 patients found that 19% of fecal microbiota transplantation (FMT) procedures reported adverse events, with the most common being mild issues like diarrhea (10%) and abdominal discomfort (7%).

Serious adverse events (SAEs) occurred in 1.4% of patients, primarily in those with mucosal barrier injury, highlighting the need for improved FMT methodologies to enhance safety, especially for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020. Marcella, C., Cui, B., Kelly, CR., et al.[2021]

Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and has become more accessible due to the availability of stool banks.

Recent studies suggest that FMT may also be beneficial for other conditions like ulcerative colitis, irritable bowel syndrome, and hepatic encephalopathy, indicating its potential for broader therapeutic applications, although more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application and Potential of Fecal Microbiota Transplantation. Ooijevaar, RE., Terveer, EM., Verspaget, HW., et al.[2022]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

Fecal microbiota transplantation (FMT) is a cost-effective treatment for recurrent Clostridium difficile infection (rCDI), with all economic evaluations showing it to be more cost-effective than other standard treatments at a threshold of ≤$50,000 per quality-adjusted life year (QALY).

The systematic review included 9 high-quality economic evaluations, primarily focusing on rCDI and inflammatory bowel disease (IBD), indicating that while FMT is effective for rCDI, further studies are needed to explore its economic impact for other conditions like IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of economic evaluation in fecal microbiota transplantation. Stalder, T., Kapel, N., Diaz, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease. Olesen, SW., Gerardin, Y.[2021]

A systematic review of 8 randomized trials involving 472 IBS patients found that fecal microbiota transfer (FMT) did not significantly improve overall IBS symptom severity compared to placebo, indicating limited efficacy of FMT for IBS treatment.

While the oral route of FMT showed some initial improvement in response rates, this did not translate into a significant reduction in symptom severity, and the benefits appeared to diminish over time, suggesting that alternative bacterial-based treatments may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fecal microbiota transplant in irritable bowel syndrome: An update based on meta-analysis of randomized control trials. Abdelghafar, YA., AbdelQadir, YH., Motawea, KR., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034505/

Fecal Microbiota Transplantation Is Highly Effective in Real ... Fecal microbiota transplantation is highly effective in real-world practice: Initial results from the FMT National Registry.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949928324000087

Review Fecal microbiota transplantation in clinical practice Fecal microbiota transplantation (FMT) effectiveness: acute enteritis > functional enteropathy > organic/chronic enteropathy > extraintestinal diseases.

3. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant

Fecal Transplant Fecal transplantation is a procedure to collect feces, also called stool or poop, from a healthy donor and introduce them into a patient's gastrointestinal ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05832-1

Fecal microbiota transplantation restores gut microbiota ... Clinical data on oral fecal microbiota transplantation (FMT), a ... Therapeutic faecal microbiota transplantation controls intestinal ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05373784

NCT05373784 | FMT in Uncomplicated Diverticulitis This study aims to assess the safety and efficacy of fecal microbiota transplantation (FMT) in treating uncomplicated diverticulitis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694295/

Safety and efficacy of faecal microbiota transplantation in ... FMT is considered a safe and effective strategy to restore a healthy diversity of the gastrointestinal microbiota in patients with recurrent ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453848/

Fecal Microbiota Transplantation: An Update on Clinical ... Data from several RCTs and a large case series revealed the efficacy and safety of FMT [9-12]. A recent systematic review and meta-analysis of 7 RCTs and 30 ...