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

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllUniversity of Rijeka
NCT07481422 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * pregnant or breastfeeding women * women of childbearing potential who are unwilling to use an acceptable method of birth control * 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) * gastrointestinal symptoms explained by an alternative diagnosis (underlying IBD, infectious enteritis) * severe allergy to capsule components * therapy with new antidepressants or had a change in antidepressant dose within previous 3 months * serious medical comorbidities (including neurological or psychiatric comorbidities) * treatment with antibiotics 3 months before enrolment * previous history of FMT at any time in the past * unwillingness to ingest the capsules
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What it tests

  • FMT capsule
  • Placebo
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Where

1 site
Clinical Hospital Center Rijeka
Rijeka, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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