NCT06551948

Effect of MethylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule

RandomisEd PlAcebo ControlLed TrIal of MethylceILulose or PSyllium on FermentaTion of Inulin Assessed Using a Gas Sensing Capsule (REALISTIC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if the investigators can show a shift of the site of fermentation to the distal colon. The investigators will achieve this using the Atmo pill, a recently developed ingestible gas-sensing wireless capsule manufactured by Atmo Biosciences. The pill is very similar in appearance and dimensions (26·8 mm long by 11·7 mm in diameter) to the Smart Pill, an FDA approved wireless capsule which measures local pH, which has been widely and safely used for over a decade. The Smart Pill is recommended for transit measurement by the American ACG Clinical Guidelines on Gastroparesis 3. The Atmo pill differs from the Smart Pill in measuring hydrogen and carbon dioxide within the colonic lumen rather than pH. The pill emits a radio signal to a small device worn by the participant to record the measurements periodically 4.

Detailed description

Aim This pilot study aims to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will delay colonic fermentation compared to inulin combined with placebo (maltodextrin), resulting in an increase in colonic hydrogen concentration in the distal colon as measured by the Atmo pill. Objective The primary objective of this pilot is to quantify in vivo the hydrogen gas produced from colonic fermentation post ingestion. Previous studies have measured hydrogen concentration from breath analysis to infer colonic fermentation progression, however the Atmo pill will allow for direct measurement throughout colonic transit. By dividing the mean colonic hydrogen gas production into time quartiles, the investigators can better associate which region of the colon the fermentation is taking place (i.e., 4th quartile to represent distal colon region). Secondary Objectives Mean colonic hydrogen% in each quarter of colonic transit. Mean colonic carbon dioxide% in each quarter of colonic transit. Colon transit time (CTT) determined from Atmo pill. Small bowel transit time (SBTT) of Atmo pill to caecum. Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr. Orocecal transit time (OCTT) from breath analysis. Whole gut transit time assessed by blue muffin test. Gas production over 48 hours incubation in vitro model of colon using participants stool samples (in collaboration with Quadram Institute). Metabolite production (short chain fatty acids) using same in vitro model of colon (in collaboration with Quadram Institute). Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	psyllium	15 g psyllium
DIETARY_SUPPLEMENT	methylcellulose	15 gm methylcellulose
DIETARY_SUPPLEMENT	maltodextrin	15 g maltodextrin
DIETARY_SUPPLEMENT	inulin	15g inulin

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-08-13
• Last updated: 2025-04-01

Locations

1 site across 1 country: United Kingdom