At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of a Multi-strain Synbiotic on Fecal Metagenomic Stability, Gut Barrier Integrity, and Metabolic Output of the Gut Microbiota
In Brief
A Phase 2 clinical trial evaluating DS-01 for Irritable Bowel Syndrome. Completed, enrolled 48 participants across 1 site.
Detailed Summary
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receive the placebo (once daily). Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects will also receive extensive education on use of the synbiotic.
Study Details
Timeline
Interventions
synbiotic