Clinical Trial

Probiotics and Biomarkers in Irritable Bowel Syndrome

Study acronym: BIO-IBS
Recruiting
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Summary
The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is: Does the probiotic alter IBS symptom severity? Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes. Participants will: Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks. Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection). Provide biological samples (blood, stool, saliva, urine) Complete questionnaires
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-06.
Trial Details
NCT Number NCT07584278
Lead Sponsor Sahlgrenska University Hospital
Conditions Irritable Bowel Syndrome (IBS)
Enrollment 252 participants
Start Date 2026-04-28
Primary Completion 2031-04 (estimated)
Study Completion 2031-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-01