Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome
LYO-IBS
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2027
March 18, 2026
March 1, 2026
1 year
March 13, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
A decrease in the IBS-SSS of at least 50 points
12 weeks
Secondary Outcomes (2)
Qualty of life
12 weeks
Hospital Anxiety and Depression Scale
12 weeks
Study Arms (2)
FMT
EXPERIMENTALLyophilized FMT capsules
Placebo
PLACEBO COMPARATORPlacebo capsules
Interventions
A total of 18 capsules containing 3060 of lyophilizate yhrough three days (three capsules twice daily)
18 capsules of identical apparence and weight given in the same way as FMT capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 13, 2026
First Posted
March 18, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
March 15, 2027
Study Completion (Estimated)
December 15, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 3 years after the publications of results.
- Access Criteria
- Data will be shared with qualified researchers for academic purposes under a data use agreement. Requests should be directed via e-mail.
De-identified individual participant data (IPD) that underlie the results resported in the publication (e.g. adverse events, changes in IBS-SSS, IBS-QoL, and HADS questionnaires) will be made available upon reasonable request. Data will be shared with qualified researchers for academic purposes under a data use agreement. Requests should be directed via e-mail.