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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Functional Abdominal Pain; Functional Gastrointestinal Disorders; Functional Abdominal Pain Syndrome; Functional Bowel Disorder; Functional Abdominal Pain Disorders
• Intervention / Treatment: Other: Cognitive Behavioral Therapy; Other: Low FODMAP 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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert J. Shulman, MD; Phone Number: 713 798-7178; Email: rshulman@bcm.edu
• Study Contact Backup: Name: Cynthia A. Boutte, BSN; Phone Number: 713 798-7178; Email: cboutte@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital
      • Contact: Cynthia A. Boutte; Phone Number: 713-798-7178; Email: cboutte@bcm.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • Children's Nutrition Research Center
      • Contact: Cynthia A. Boutte; Phone Number: 713-798-7178; Email: cboutte@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy	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 .
Experimental: Low FODMAP diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Improvement	Abdominal pain frequency or severity	3 to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in quality of life	PedsQL or Functional Disability	3 months
Symptom Improvement	Abdominal pain frequency or severity	3 months
Improvement in quality of life	PedsQL or Functional Disability	6 months
Symptom Improvement	Abdominal pain frequency or severity	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in quality of life	PedsQL or Functional Disability	3 to 4 weeks

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: University of Washington
• Investigators: Principal Investigator: Robert J. Shulman, MD, Baylor College of Medicine; Principal Investigator: Rona Levy, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Syndrome; Irritable Bowel Syndrome; Chronic Pain; Abdominal Pain; Somatoform Disorders; Gastrointestinal Diseases; Digestive System Diseases; Pain; Intestinal Diseases
• Other Study ID Numbers: H-43391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No