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

Completed · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Functional Bowel Disorder, Functional Abdominal Pain, Functional Abdominal Pain Disorders

In brief

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.

Key facts

Study ID

NCT03823742

Run by

Baylor College of Medicine

People needed

163

Starts

2019-02-22

Expected to finish

2025-12-31

Last updated by the study team

2026-03-24

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Children's Nutrition Research Center — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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