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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .
Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.
Children's Nutrition Research Center
Houston, Texas, United States
RECRUITINGTexas Children's Hospital
Houston, Texas, United States
RECRUITINGSymptom Improvement
Abdominal pain frequency or severity
Time frame: 3 to 4 weeks
Improvement in quality of life
PedsQL or Functional Disability
Time frame: 3 months
Symptom Improvement
Abdominal pain frequency or severity
Time frame: 3 months
Improvement in quality of life
PedsQL or Functional Disability
Time frame: 6 months
Symptom Improvement
Abdominal pain frequency or severity
Time frame: 6 months
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