An interventional study of Psyllium and Methylcellulose in Irritable Bowel Syndrome, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by University of Nottingham · Not applicable, Interventional, and Basic science
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.
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:
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
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of Nottingham is the lead sponsor of 463 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Psyllium 15 g+ inulin 15 gm in 375ml water
Dietary Supplement: Psyllium
Maltodextrin 15 g + inulin 15 gm in 375 ml water
Dietary Supplement: Maltodextrin
Methylcellulose 15g + Inulin 15 g in 375 ml water
Dietary Supplement: Methylcellulose
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
Breath hydrogen
AUC 0-6 hours after ingestion
Time frame: 0-6 hoursafter ingestion
Breath hydrogen
AUC 0-24 hours
Time frame: 0-24 hours post ingestion
Breath methane
AUC 0-24 hours
Time frame: 0-24 hours post ingestion
Transit time
whole gut transit time
Time frame: Whole gut transit measured once before intervention
Plan to share: No
Ran from May 2023 to primary completion in Aug 2023, 3 months.
Of 297 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 3 months is below that.
Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylcellulose