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Tests treatment safety and results for Irritable Bowel Syndrome (IBS)
Official title Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT07481422
What this study is testing
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- negative evaluation for coeliac disease
- signed informed consent
You likely can't join 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rijeka, Croatia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rijeka, Croatia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.