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

NCT03823742 | Completed

• 1 other identifier: H-43391
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Symptom Improvement

  Abdominal pain frequency or severity

  3 to 4 weeks

Secondary Outcomes (4)

• Improvement in quality of life

  3 months

• Symptom Improvement

  3 months

• Improvement in quality of life

  6 months

• Symptom Improvement

  6 months

Other Outcomes (1)

• Improvement in quality of life

  3 to 4 weeks

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive Behavioral Therapy

Other: Cognitive Behavioral Therapy

Low FODMAP diet

EXPERIMENTAL

Low FODMAP diet

Other: Low FODMAP Diet

Interventions

Cognitive Behavioral Therapy OTHER

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 .

Cognitive Behavioral Therapy

Low FODMAP Diet OTHER

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.

Low FODMAP diet

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A child 7-12 years of age with a FGID will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the pediatric Rome III criteria (Rome IV will be substituted when validated). Parents and children must speak and understand English because of the psychological assessment and CBT requirements.

You may not qualify if:

• Children who have: had past bowel surgery; documented GI disorders (e.g., Crohn's disease); a serious chronic medical condition (e.g., diabetes); weight and/or height \< 2 SD for age; chronic conditions with GI symptoms (e.g., cystic fibrosis); autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on gut microbiome analysis), and children who for some reason could not be randomized to the low FODMAP diet.Vegetarian; children who are currently on the FODMAP Diet or receiving CBT Children who speak only Spanish are not eligible because the Rome questionnaire and psychological testing are not available in Spanish. Despite this, a large proportion of the children enrolled will be Hispanic.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Washington: collaborator

Study Sites (2)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Interventions

Cognitive Behavioral Therapy; FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert J. Shulman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Rona Levy, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The proposed study is a randomized trial with a two group design. Children will be equally likely to be randomized to either CBT or a low FODMAP diet. There is no placebo treatment and no healthy controls are to be studied. Subjects will be stratified based on age (7-9 vs 10-12), sex, baseline pain (mean pain frequency: less than or equal to 50% of the rated intervals or \> 50% of the rated intervals, as reported on the baseline pain and stool diary) and PedsQL.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: February 22, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)