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Effect of Modified Cellulose on Colonic Fermentation of Inulin

NCT05911347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-15

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Psyllium

15g psyllium added to inulin solution to form a gel

DIETARY_SUPPLEMENT

Methylcellulose

15 g methylcellulose added to inulin solution to form a gel

DIETARY_SUPPLEMENT

Maltodextrin

15g maltodextrin added to inulin solution to form a gel

Sponsors & Collaborators

  • University of East Anglia

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Robin D Spiller, MD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911347 on ClinicalTrials.gov