NCT07481422 Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome
| NCT ID | NCT07481422 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Rijeka |
| Condition | Irritable Bowel Syndrome (IBS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-03-15 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2026-03-15 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Irritable Bowel Syndrome (IBS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481422 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07481422 currently recruiting?
Yes, NCT07481422 is actively recruiting participants. Contact the research team at dora.palcevski@gmail.com for enrollment information.
Where is the NCT07481422 trial being conducted?
This trial is being conducted at Rijeka, Croatia.
Who is sponsoring the NCT07481422 clinical trial?
NCT07481422 is sponsored by University of Rijeka. The trial plans to enroll 70 participants.