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Effect of Modified Cellulose on Colonic Fermentation of Inulin — COCOA2  

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)

Clinical Trial 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. We will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.

Clinical Trial Description

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. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring. Secondary endpoint: 1. AUC (0-24h) breath hydrogen / methane 2. Oro-cecal transit time and whole gut transit time. 3. Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram 4. Effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin. The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses: Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05911347
Study type Interventional
Source University of Nottingham
Contact Joshua Read, PhD
Phone +44 115 9249924
Email joshua.read@nottingham.ac.uk
Status Recruiting
Phase N/A
Start date May 9, 2023
Completion date August 31, 2023
View Details
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