Using biomarkers to predict treatment response in children with chronic abdominal pain
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
This study is testing if certain biological markers can help predict which kids aged 7-12 with stomach issues will do better with therapy or a special diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT03823742 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if specific biomarkers can predict which children aged 7-12 with functional gastrointestinal disorders (FGIDs) will benefit more from cognitive behavioral therapy (CBT) or a low FODMAP diet. It will categorize 250 children based on physiological changes related to gut function and autonomic nervous system balance. Participants will be randomly assigned to either CBT or the low FODMAP diet for three weeks, with their responses evaluated at three different time points: three weeks, three months, and six months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-12 diagnosed with functional gastrointestinal disorders who have no organic cause for their abdominal pain.
Not a fit: Patients with documented gastrointestinal disorders, serious chronic medical conditions, or significant developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for children suffering from chronic abdominal pain.
How similar studies have performed: Other studies have shown promise in using biomarkers for treatment response prediction, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas and 1 other locations
- Children's Nutrition Research Center — Houston, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Robert J. Shulman, MD — Baylor College of Medicine
- Study coordinator: Robert J. Shulman, MD
- Email: rshulman@bcm.edu
- Phone: 713 798-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.