Clinical trial NCT06639984: Psyllium in Pediatric IBS
Official title: Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Abdominal Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-15
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS

Exclusion Criteria:

* Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
* weight and/or height are \&gt; or \&lt; 2 SD for age
* have chronic conditions with GI symptoms (e.g., cystic fibrosis)
* have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
* girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)

Primary outcomes:
measure: Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
timeFrame: Baseline, 2 weeks
measure: Change in fecal lactate
timeFrame: Baseline, 2 weeks
measure: Change in fecal short-chain fatty acids
timeFrame: Baseline, 2 weeks
measure: Change in hydrogen gas production
timeFrame: Baseline, 2 weeks
measure: Change in fecal fructans
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Change in abdominal pain frequency
timeFrame: Baseline, 2 weeks
measure: Change in abdominal pain severity
timeFrame: Baseline, 2 weeks
measure: Change in bloating severity
timeFrame: Baseline, 2 weeks
measure: Change in flatulence severity
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Bruno Chumpitazi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: