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Effect of Modified Cellulose on Colonic Fermentation of Inulin - Trial NCT05911347

Access comprehensive clinical trial information for NCT05911347 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Nottingham and is currently Recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 30 participants.

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NCT05911347
Recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT05911347
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Effect of Modified Cellulose on Colonic Fermentation of Inulin
Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)

Study Focus

Irritable Bowel Syndrome

Psyllium

Interventional

dietary supplement

Sponsor & Location

University of Nottingham

Nottingham, United Kingdom

Timeline & Enrollment

N/A

May 09, 2023

Aug 31, 2023

30 participants

Primary Outcome

Breath hydrogen

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.

ICD-10 Classifications

Irritable bowel syndrome
Other and unspecified irritable bowel syndrome
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Irritable bowel syndrome with predominant constipation [IBS-C]
Irritable bowel syndrome with predominant diarrhoea [IBS-D]

Data Source

ClinicalTrials.gov

NCT05911347

Non-Device Trial