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Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?

Irritable Bowel Syndrome Clinical Trial

Official title:
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03823742
Study type Interventional
Source Baylor College of Medicine
Contact Robert J. Shulman, MD
Phone 713 798-7178
Email rshulman@bcm.edu
Status Recruiting
Phase N/A
Start date February 22, 2019
Completion date December 31, 2024
View Details
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