Fecal microbiota transplant for adults with refractory irritable bowel syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Ling Dong — Fudan University
• Study coordinator: Shengdi Wu
• Email: wu.shengdi@zs-hospital.sh.cn
• Phone: (86)13817923359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.