Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551948
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
methylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RandomisEd plAcebo controlLed trIal of methylceILulose or pSyllium on FermentaTion of Inulin Assessed Using a Gas Sensing Capsule REALISTIC
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REALISTIC
Brief Summary:
We plan to measure the local in vivo production of hydrogen when methylcellulose is ingested to see if we can show a shift of the site of fermentation to the distal colon
We 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 268 mm long by 117 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
We 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 268 mm long by 117 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
Our aim for this pilot study is 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 we can better associate which region of the colon the fermentation is taking place ie 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
Our aim for this pilot study is 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 we can better associate which region of the colon the fermentation is taking place ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None