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

10 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{2 3 6 9 10}

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

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]

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]

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]

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) 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 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]

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]

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 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]

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]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Resolution of multiply recurrent and multifocal diverticulitis after fecal microbiota transplantation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation: establishment of a clinical application framework. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fecal Transplantation for Treatment of Clostridium Difficile Infection in Elderly and Debilitated Patients. [2020]

6. United States 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. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? [2021]

8. England pubmed.ncbi.nlm.nih.gov

Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A systematic review of economic evaluation in fecal microbiota transplantation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Application and Potential of Fecal Microbiota Transplantation. [2022]