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

CompletedNot applicableNCT03823742
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Conditions
  • Irritable Bowel Syndrome
  • Functional Abdominal Pain Syndrome
  • Functional Gastrointestinal Disorders
  • Functional Bowel Disorder
  • Functional Abdominal Pain
  • Functional Abdominal Pain Disorders
Interventions
  • Other: Cognitive Behavioral Therapy
  • Other: Low FODMAP Diet
Sponsor
Baylor College of Medicine
Collaborators
University of Washington
Start date
2019-02-22
Primary completion
2024-12-31
Sex
All
Age range
from 7 Years to 12 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03823742