Fecal Microbiota Transplant for Irritable Bowel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
Will I have to stop taking my current medications?
The trial requires that you stop taking new probiotics, antibiotics, and NSAIDs (non-steroidal anti-inflammatory drugs) at least 4 weeks before joining. You also cannot use treatments that affect bowel movement, except for loperamide.
Is fecal microbiota transplantation (FMT) safe for humans?
How is fecal microbiota transplantation (FMT) different from other treatments for irritable bowel syndrome (IBS)?
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation for Irritable Bowel Syndrome?
Research suggests that Fecal Microbiota Transplantation (FMT) can be a promising treatment for irritable bowel syndrome (IBS) by restoring the balance of gut bacteria, which is often disrupted in IBS patients. Studies have shown that FMT can improve symptoms and quality of life, although the effectiveness may vary based on factors like the number of FMT infusions and patient characteristics.36789
Who Is on the Research Team?
Madhusudan Grover, MBBS
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with post-infection irritable bowel syndrome (PI-IBS) who experience moderate to severe symptoms. They must be able to undergo a colonoscopy and not have constipation-dominant IBS. People with recent abdominal surgery, bleeding disorders, low neutrophil count, active cancer, certain GI diseases, or those pregnant or on immune-suppressing drugs cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fecal microbiota transplantation (FMT) using stool from a donor or their own stool
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Fecal Microbiota Transplantation
- Donor Fecal Microbiota Transplantation
Autologous Fecal Microbiota Transplantation is already approved in European Union, United States, Canada for the following indications:
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Who Is Running the Clinical Trial?
Madhusudan (Madhu) Grover, MBBS
Lead Sponsor