Fecal microbiota transplant for adults with refractory irritable bowel syndrome

Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

This project will try monthly fecal microbiota transplants—given as oral capsules or through a tube to the small intestine—to see if symptoms improve in adults (18–70) with IBS who haven't responded to at least three treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05740319 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm interventional protocol enrolling adult patients with refractory IBS who meet Rome IV criteria. Participants receive fecal microbiota transplantation from screened healthy donors three times at monthly intervals, delivered either as oral capsules or by nasojejunal tube into the duodenum. Symptom severity, gastrointestinal symptoms, anxiety, depression, and quality of life are measured with validated scales at baseline, after FMT, and at 1, 2, 3 and 4 months post-treatment, and fecal samples are collected at each visit. Primary endpoints are improvement in IBS-SSS score and global symptoms after the three treatments, and secondary endpoints include GSRS changes, emotional and quality-of-life measures, and changes in fecal microbiota composition.

Who should consider this trial

Good fit: Adults aged 18–70 who meet Rome IV criteria for IBS and have failed at least three conventional therapies, without red-flag symptoms, are the intended participants.

Not a fit: Patients who are pregnant or lactating, have immunodeficiency or uncontrolled systemic disease, recent antibiotic or probiotic use, severe psychiatric illness, or inability to comply with follow-up are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, this approach could reduce IBS symptom severity and improve patients' quality of life and emotional well-being.

How similar studies have performed: Previous randomized and observational studies of FMT for IBS have produced mixed results, with some patients showing symptom improvement but overall inconsistent efficacy across trials.

Eligibility criteria

Inclusion Criteria:

* Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
* Patients who have experienced failure of at least 3 conventional therapies for IBS;
* Absence of red flags such as weight loss, hematochezia;

Exclusion Criteria:

* Pregnant, planning pregnancy or lactating;
* Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
* Immunodeficiency or treatment with immune-modulating medication;
* Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
* Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
* Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ling Dong — Fudan University
• Study coordinator: Shengdi Wu

Conditions Irritable Bowel Syndrome