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

Recruiting Phase 1 Phase 2 Interventional Study
Irritable Bowel Syndrome (IBS)
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
University of Rijeka · Other
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About This Trial
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 FM…
Trial Locations
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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, SSR…
Contacts

Dora Palčevski, MD

+385917293984

dora.palcevski@gmail.com

CONTACT

Nataša Skočibušić, mag. clin. nutr.

+38551658783

natasa.skocinusic@kbc-rijeka.hr

CONTACT