NCT03823742

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome
• Functional Abdominal Pain Syndrome
• Functional Gastrointestinal Disorders
• Functional Bowel Disorder
• Functional Abdominal Pain
• Functional Abdominal Pain Disorders

Interventions

Type	Name	Description
OTHER	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .
OTHER	Low FODMAP Diet	Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.

Timeline

• Start date: 2019-02-22
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2019-01-30
• Last updated: 2026-03-24

Locations

2 sites across 1 country: United States