At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
In Brief
A clinical study evaluating Psyllium, Methylcellulose, and 1 other intervention for Irritable Bowel Syndrome. Completed, enrolled 30 participants across 1 site.
Detailed Summary
A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. The investigators will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.
Study Details
Timeline
Interventions
15g psyllium added to inulin solution to form a gel
15 g methylcellulose added to inulin solution to form a gel
15g maltodextrin added to inulin solution to form a gel