Status:
RECRUITING
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of Washington
Conditions:
Irritable Bowel Syndrome
Functional Abdominal Pain Syndrome
Eligibility:
All Genders
7-12 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03823742
Start Date
February 22 2019
End Date
December 31 2025
Last Update
September 22 2025
Active Locations (2)
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1
Children's Nutrition Research Center
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030