Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome
Key facts
- Where
- Rijeka, CroatiaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07481422, who can take part
Where in Croatia
- Clinical Hospital Center RijekaRijeka, CroatiaContact: Nataša Skočibušić, mag. clin. nutr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Rijeka
- Trial code
- NCT07481422
- Record updated
- 18 March 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 18-65 years of age; disease activity defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175; symptoms refractory to conservative medical therapy (hyoscine salts, osmotic laxatives such as polyethylene glycol, loperamide, rifaximin, tricyclic antidepressants, SSRIs or other antidepressants, peppermint oil); negative evaluation for coeliac disease; signed informed consent.
Exclusion: therapy with new antidepressants or had a change in antidepressant dose within previous 3 months; treatment with antibiotics 3 months before enrolment; previous history of FMT at any time in the past; severe allergy to capsule components; serious medical comorbidities (including neurological or psychiatric comorbidities); severely immunocompromised or immunosuppressed (organ transplant recipients, those with neutropenia with an absolute neutrophil count of <500 cells per mm3, those receiving current treatment with antineoplastic drugs, HIV positive); pregnant or breastfeeding women; women of childbearing potential who are unwilling to use an acceptable method of birth control; gastrointestinal symptoms explained by an alternative diagnosis (underlying IBD, infectious enteritis); unwillingness to ingest the capsules.