Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
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.
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 imbalance as indicated by low heart rate variability; and/or (b) Abnormalities
 in gut physiology: Impaired gut barrier function (increased permeability); and/or increased
 abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune
 dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations).

 AIM 2: Children will be randomized to the two treatments most commonly used in clinical
 practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the
 response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks,
 3 months, and 6 months.
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.