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

NCT03823742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Robert J. Shulman, MD · Baylor College of Medicine

  • Rona Levy, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823742 on ClinicalTrials.gov