Using fecal microbiota transplantation to treat irritable bowel syndrome
Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study
NA · Thammasat University · NCT06201182
This study is testing whether a treatment using healthy gut bacteria can help people with irritable bowel syndrome feel better compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Thammasat University (other) |
| Locations | 1 site (Pathumthani) |
| Trial ID | NCT06201182 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome (IBS) in Thailand. Participants will be randomly assigned to one of three groups: a placebo group receiving placebo capsules and enemas, an enema group receiving FMT via rectal enema and placebo capsules, and a capsule group receiving FMT capsules and placebo enemas. The study will compare the outcomes of FMT against placebo to determine if it provides better relief from IBS symptoms. Additionally, it will assess the effectiveness of FMT delivered via rectal enema versus encapsulated FMT.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 diagnosed with IBS according to the Rome IV criteria.
Not a fit: Patients with severe comorbidities, fecal incontinence, or those who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, less invasive treatment option for patients suffering from IBS.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of FMT for IBS, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-70 years with IBS diagnosed by Rome IV criteria * Patients who can provide written informed consent. Exclusion Criteria: * Pregnant or breastfeeding women * Severe comorbidities: chronic kidney disease (GFR\<15 ml/min), cirrhosis, cancer, etc. * Fecal incontinence * Immunocompromised patients * Taking probiotic, or fermented food * Discontinue medication for IBS \<1 month prior to study inclusion
Where this trial is running
Pathumthani
- Thammasat University — Pathumthani, Thailand (RECRUITING)
Study contacts
- Study coordinator: Natsuda Aumpan, MD
- Email: aumpan.natsuda@gmail.com
- Phone: +66870494808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome, Fecal microbiota transplantation