RecruitingPhase 1Phase 2NCT07481422

Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome


Sponsor

University of Rijeka

Enrollment

70 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if oral capsules containing lyophilized fecal microbiota transplantation (FMT) can safely and effectively treat refractory irritable bowel syndrome (IBS) in adults aged 18-65 years. The main questions it aims to answer are: Does treatment with lyophilized FMT capsules reduce IBS symptom severity compared with placebo? Does treatment with lyophilized FMT capsules improve quality of life, anxiety, and depression in patients with IBS? Are there differences in the frequency of adverse events between participants receiving FMT capsules and those receiving placebo? Researchers will compare lyophilized FMT capsules to placebo capsules to see if FMT reduces IBS symptoms and improves quality of life and mental health. Participants will: Be randomly assigned to receive either lyophilized FMT capsules or placebo capsules for three consecutive days. Take the capsules under supervision after receiving a proton pump inhibitor before the first dose. Complete questionnaires assessing symptom severity, quality of life, anxiety, and depression at baseline, 4 weeks, and 12 weeks after treatment. Attend follow-up visits at 4 weeks and 12 weeks after treatment and receive a telephone follow-up call 10 days after capsule ingestion. Report any adverse events and have vital signs and medical information monitored during follow-up. This study will help determine whether oral lyophilized FMT capsules are a safe and effective treatment option for adults with refractory IBS.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether oral capsules containing freeze-dried (lyophilized) fecal microbiota transplantation (FMT) — essentially a concentrated dose of healthy gut bacteria from a screened donor — can safely and effectively reduce symptoms of irritable bowel syndrome (IBS) that hasn't responded to standard treatments. IBS is a common gut condition causing chronic pain, bloating, and altered bowel habits, and there's growing evidence that gut bacteria play a key role. Adults aged 18 to 65 with an established IBS diagnosis, moderate-to-severe symptoms, and failure of standard therapies may be eligible, while pregnant women, severely immunocompromised individuals, and those with other explanations for their symptoms are excluded. Participation involves taking 3 capsules per day for 3 consecutive days under supervision, then completing questionnaires at 4 weeks and 12 weeks to measure symptom severity, quality of life, and mood. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFMT capsule

A total of 18 capsules containing 3060 of lyophilizate yhrough three days (three capsules twice daily)

OTHERPlacebo

18 capsules of identical apparence and weight given in the same way as FMT capsules


Locations(1)

Clinical Hospital Center Rijeka

Rijeka, Croatia

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NCT07481422


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