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

NCT ID: NCT03823742

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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 .

Low FODMAP diet

Low FODMAP diet

Group Type: EXPERIMENTAL

Low FODMAP Diet

Intervention Type: 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.

Interventions

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 .

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Robert Shulman, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J. Shulman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Rona Levy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Children's Nutrition Research Center

Houston, Texas, United States

Site Status: RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert J. Shulman, MD

Role: CONTACT

rshulman@bcm.edu

713 798-7178

Cynthia A. Boutte, BSN

Role: CONTACT

cboutte@bcm.edu

713 798-7178

Facility Contacts

Cynthia A. Boutte

Role: primary

cboutte@bcm.edu

7137987178

Cynthia A. Boutte

Role: primary

cboutte@bcm.edu

7137987178

Other Identifiers

H-43391

Identifier Type: -

Identifier Source: org_study_id