An interventional study of Cognitive Behavioral Therapy and Low FODMAP Diet in Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome and Functional Gastrointestinal Disorders, sponsored by Baylor College of Medicine. Completed at 2 sites in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 163 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cognitive Behavioral Therapy
Other: Cognitive Behavioral Therapy
Low FODMAP diet
Other: Low FODMAP Diet
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.
Symptom 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
Improvement in quality of life
PedsQL or Functional Disability
Time frame: 3 to 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine