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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Irritable Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Houston

Children's Nutrition Research Center, Houston, Texas, United States, 77030

Houston

Texas Children's Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

7 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Robert J. Shulman, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Rona Levy, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2024-12-31