Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639984
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Psyllium in Pediatric IBS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Psyllium
Brief Summary:
The goal of this clinical trial is to learn if a fiber psyllium can change the way bacteria use fructans a type of sugar and whether psyllium can help decrease childhood irritable bowel syndrome IBS symptoms when eating fructans The main questions it aims to answer are
Aim 1 The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation intracolonic pH H2 gas production gut microbiome composition fecal short-chain fatty acids lactate glycomics
Aim 2 Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms Those with worsening symptoms with fructans will be asked to participate in the second part of the study This includes two weeks of baseline no change in diet and two weeks of eating a specific diet with fructans with either psyllium or glucose Participants will be asked to complete pain and stool diaries submit stool specimens swallow a pill to capture gut acid levels and give breath samples
Aim 1 The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation intracolonic pH H2 gas production gut microbiome composition fecal short-chain fatty acids lactate glycomics
Aim 2 Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms Those with worsening symptoms with fructans will be asked to participate in the second part of the study This includes two weeks of baseline no change in diet and two weeks of eating a specific diet with fructans with either psyllium or glucose Participants will be asked to complete pain and stool diaries submit stool specimens swallow a pill to capture gut acid levels and give breath samples
Detailed Description:
None
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