Using fecal microbiota transplantation to treat irritable bowel syndrome

Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

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
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou First People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03613545 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who meet the Rome IV criteria for irritable bowel syndrome.

Not a fit: Patients with severe diseases such as liver or kidney failure, cancers, or inflammatory bowel disease may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Guangzhou, Guangdong

• 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

Conditions Irritable Bowel Syndrome; Fecal Microbiota Transplantation