A Treatment Invention for Children With Functional Gastrointestinal Pain

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.