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The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from CBT or from the low FODMAPs diet.
AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities in gut physiology: Impaired gut barrier function (increased permeability); and/or increased abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations). AIM 2: Children will be randomized to the two treatments most commonly used in clinical practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks, 3 months, and 6 months.
Age
7 - 12 years
Sex
ALL
Healthy Volunteers
No
Children's Nutrition Research Center
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Start Date
February 22, 2019
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2025
Last Updated
September 22, 2025
250
ESTIMATED participants
Cognitive Behavioral Therapy
OTHER
Low FODMAP Diet
OTHER
Lead Sponsor
Baylor College of Medicine
Collaborators
NCT07481422
NCT05740319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07089420