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

Launched by BAYLOR COLLEGE OF MEDICINE · Jan 29, 2019

Keywords

ClinConnect Summary

This clinical trial is looking to see if simple tests, called biomarkers, can help predict whether children with certain types of stomach pain, like Irritable Bowel Syndrome (IBS), will benefit more from a specific type of therapy known as Cognitive Behavioral Therapy (CBT) or from following a diet low in certain carbohydrates called the low FODMAP diet. The study aims to help doctors better understand how to treat children aged 7-12 years who experience ongoing abdominal pain without any clear medical reason.

To participate, children must be between 7 and 12 years old and have been diagnosed with a Functional Gastrointestinal Disorder (FGID), which means their stomach pain doesn't have an underlying medical cause. Children with certain medical issues, such as those who have had bowel surgery or have serious chronic conditions, are not eligible for this trial. If selected, participants can expect to take part in assessments and treatments that could provide relief from their symptoms while helping researchers learn more about effective pain management strategies for kids. It's important to note that both the child and their parent or guardian must be comfortable speaking and understanding English for the study's requirements.

Gender

ALL

Eligibility 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.