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NCT05911347

Effect of Modified Cellulose on Colonic Fermentation of Inulin

Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
University of Nottingham·ClinicalTrials.gov·dietary supplementRecruiting
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Study focus
Disease/Condition
Irritable Bowel Syndrome
Drug/Device/Intervention
Psyllium
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
University of Nottingham
Location
Nottingham, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
May 09, 2023
End date
Aug 31, 2023
Enrollment
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 syndromeOther and unspecified irritable bowel syndromeIrritable 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
Registry
ClinicalTrials.gov
Trial ID
NCT05911347
Type
Non-Device Trial
About this record

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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