Using fecal microbiota transplantation to treat irritable bowel syndrome
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Run by Guangzhou First People's Hospital · NCT03613545 · Data updated 2026-11-12
This study is testing whether using healthy gut bacteria from donors can help people with irritable bowel syndrome feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Guangzhou First People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 10, 2018 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | August 3, 2021 |
| Trial ID | NCT03613545 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 75 who meet the Rome IV criteria for irritable bowel syndrome.
✕Probably not a fit
Patients with severe diseases such as liver or kidney failure, cancers, or inflammatory bowel disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness and safety of fecal microbiota transplantation (FMT) as a treatment for patients with irritable bowel syndrome (IBS). The study involves infusing a fecal suspension from healthy donors into the patients' colons to restore a balanced gut microbiome. Participants will receive FMT at least twice and will be monitored for a minimum of six months using questionnaires to assess their symptoms and overall gut health. The trial is conducted at Guangzhou First People's Hospital, focusing on a standardized approach to microbiota isolation and transplantation.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from irritable bowel syndrome.
How similar studies have gone: While fecal microbiota transplantation has shown success in treating recurrent Clostridium difficile infections, its application for irritable bowel syndrome is less established, making this study a novel exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: To be considered eligible for enrolment into the study, subjects must: * Be able to give written informed consent. * Males and females aged \>18 and \<75 * Have IBS as defined by the Rome IV criteria Exclusion Criteria: Subjects will be excluded from the study if they meet any of the below criteria: * pregnant or having a follow-up of less than 6 months; * unable to give informed consent; * suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection; * unable to undergo endoscopy.
Where it's running
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Hongli Huang, MM — Guangzhou First People's Hospital
- Study coordinator: Hongli Huang, MM
- Email: honglisums@126.com
- Phone: 86-13631316718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.