Poop Transplant for Pouchitis

Overseen By Neeraj Narula

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Disqualifiers: Severe illness, C. difficile, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

FMT has shown effectiveness in treating Clostridium difficile infections by improving gut microbiota diversity, but its benefits for pouchitis are unclear. Some studies suggest FMT may alter gut bacteria in pouchitis patients, but significant clinical improvements have not been consistently observed, indicating more research is needed. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) safe for humans?

FMT is generally considered safe and well-tolerated, especially for treating recurrent Clostridioides difficile infections. Most short-term risks are mild and related to how the treatment is given, but long-term safety data is limited. Serious adverse events have been linked to FMT products from stool banks that did not screen for drug-resistant bacteria. ^{1 3 6 7 8}

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

FMT is unique because it involves transferring stool from a healthy donor to a patient to restore a balanced gut microbiota, which is different from traditional treatments that may use medications to reduce inflammation or infection. This approach is still being studied for pouchitis, as its effectiveness and optimal method of administration are not yet fully understood. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for adults over 18 with active pouchitis, which means they have inflammation in their intestinal pouch. Women who can have children must use birth control as per guidelines. People can't join if they can't consent, have a C. difficile infection, severe other illnesses, or are in another trial.

Inclusion Criteria

I am 18 years old or older.

I have active inflammation of my pouch with moderate to severe symptoms.

I am willing to use birth control as required.

Exclusion Criteria

Severe comorbid medical illness

I am currently infected with Clostridium difficile.

Participating in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fecal microbiota transplantation or placebo once weekly for six weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Fecal Microbiota Transplantation
• Placebos

Trial Overview The study at McMaster University tests if fecal microbiota transplantation (FMT) helps patients with pouchitis enter remission better than a placebo does. Participants receive either FMT or placebo once weekly for six weeks and are randomly assigned to one of these two groups without knowing which one.

Participant Groups

Group I: FMT Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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

Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

Fecal microbiota transplant (FMT) appears to be safe for patients with chronic pouchitis, as indicated by the four studies reviewed, but its efficacy is limited, with only a few patients achieving sustained clinical remission.

Out of the studies, only one showed a significant clinical response, with 75% of patients in that study reaching remission, while the overall results suggest that more research is needed to better understand the effectiveness of FMT for both acute and chronic pouchitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Fecal Microbiota Transplant for the Management of Pouchitis. Kayal, M., Lambin, T., Pinotti, R., et al.[2023]

In a study involving 8 patients with chronic pouchitis, faecal microbiota transplantation (FMT) led to variable changes in the composition of gut microbiota, indicating potential shifts towards a healthier microbiota.

Despite these changes, FMT did not result in significant improvements in metabolic, immunological responses, or clinical outcomes, suggesting that the current method of FMT administration may need further optimization for effective treatment of pouchitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variable alterations of the microbiota, without metabolic or immunological change, following faecal microbiota transplantation in patients with chronic pouchitis. Landy, J., Walker, AW., Li, JV., et al.[2023]

Faecal microbiota transplantation (FMT) showed a clinical response rate of 42.6% and a remission rate of 29.8% in treating chronic pouchitis, based on a systematic review of 9 studies involving 103 patients.

The treatment was well tolerated with minor, self-limiting adverse events reported, indicating a good safety profile, but the evidence is limited and calls for more rigorous studies to better assess FMT's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation (FMT) in the treatment of chronic refractory pouchitis: A systematic review and meta-analysis. Zaman, S., Akingboye, A., Mohamedahmed, AYY., et al.[2023]

In a pilot study involving 19 patients with chronic pouchitis, fecal microbiota transplantation (FMT) was found to be safe, with no major adverse events reported, and it led to a significant reduction in bowel movement frequency from 9.25 to 7.25 per day.

While FMT did not result in significant changes in endoscopic or histologic scores, there was a trend towards improvement in abdominal pain, suggesting potential benefits in symptom management for pouchitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation in Pouchitis: Clinical, Endoscopic, Histologic, and Microbiota Results from a Pilot Study. Selvig, D., Piceno, Y., Terdiman, J., et al.[2020]

In a study involving 15 patients with inflammatory bowel disease (IBD), 73% achieved remission just 3 days after a single fecal microbiota transplantation (FMT), indicating rapid therapeutic effects.

The study found that bacterial colonization was generally lower in patients with Crohn's disease compared to those with ulcerative colitis, suggesting that the type of IBD may influence the effectiveness of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation results in bacterial strain displacement in patients with inflammatory bowel diseases. Zou, M., Jie, Z., Cui, B., et al.[2021]

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 recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

Fecal microbiota transplantation (FMT) has a reported adverse event (AE) rate of 39.3%, primarily involving mild and self-limiting issues like abdominal pain and diarrhea, based on a meta-analysis of 9 high-quality studies involving 756 FMTs.

Serious adverse events (SAE) were relatively rare at 5.3%, with the most common being Clostridium difficile infection, indicating that while FMT is generally safe, monitoring and standardized reporting are essential for understanding its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. Michailidis, L., Currier, AC., Le, M., et al.[2022]

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]

Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.

However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. Rode, AA., Chehri, M., Petersen, AM., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of Fecal Microbiota Transplant for the Management of Pouchitis. [2023]

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

Variable alterations of the microbiota, without metabolic or immunological change, following faecal microbiota transplantation in patients with chronic pouchitis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Faecal microbiota transplantation (FMT) in the treatment of chronic refractory pouchitis: A systematic review and meta-analysis. [2023]

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

Fecal Microbiota Transplantation in Pouchitis: Clinical, Endoscopic, Histologic, and Microbiota Results from a Pilot Study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation results in bacterial strain displacement in patients with inflammatory bowel diseases. [2021]

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

Fecal Microbiota Transplantation: Is It Safe? [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]

8. Greece pubmed.ncbi.nlm.nih.gov

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Denmark pubmed.ncbi.nlm.nih.gov

[Faecal microbiota transplantation for the treatment of bowel disease]. [2019]