Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI — RUFUS  

Colon, Irritable Clinical Trial

Official title: Randomised Placebo Controlled Trial of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI (RUFUS)

Status Recruiting

Clinical Trial Summary

Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme.

Clinical Trial Description

Aim Our aim is to pilot the next study which will test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will reduce colonic gas volumes assessed by MRI 0-6 hours and 24 hours post ingestion as compared to inulin combined with placebo, maltodextrin.

Objective The primary objective of this pilot is to find the minimum dose which will clearly show the effect of methylcellulose and /or psyllium on colonic gas as assessed by MRI. Previous studies have used large doses to ensure a large effect to avoid a type II error however the doses used are well outside the normal consumption. We wish to compare the effect of our methylcellulose mix on the fermentation of 10 and 15 g of inulin by offering different doses of fibre gel drink.,

Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, OCTT by MRI assessment of arrival of "head of meal", regional MRI colonic appearances, including signal intensity at 6 and 24 hours to determine the likely length of effect, C) to asses breath hydrogen production over 24 hour post ingestion including overnight assessments, D) to assess Whole Gut Transit Time (WGTT) using blue muffins test, E) to measure AUC (0-24) for breath methane; F) to measure gas production over 48 hours incubation in vitro model of colon (in collaboration with Quadram Institute); G) to measure metabolite production (short chain fatty acids) using in vitro model of colon(in collaboration with Quadram Institute); H) to analyse microbiota using 16sRNA gene (in collaboration with Quadram Institute); I) to assess the effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin. ;

Related Conditions & MeSH terms

• Colon, Irritable
• Irritable Bowel Syndrome

• NCT number: NCT06291272
• Study type: Interventional
• Source: University of Nottingham
• Contact: Robin Spiller
• Phone: +447824328319
• Email: robin.spiller@nottingham.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Completion date: October 30, 2024