CBT + Low FODMAP Diet for IBS
Trial Summary
What is the purpose of this trial?
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.
Research Team
Robert J. Shulman, MD
Principal Investigator
Baylor College of Medicine
Rona Levy, PhD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for children aged 7-12 with functional gastrointestinal disorders like IBS, who experience abdominal pain without an organic cause. They must understand English due to the nature of assessments and treatments involved. Kids with past bowel surgery, chronic diseases like Crohn's or diabetes, developmental disorders, or those already on FODMAP diets or CBT are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Children are randomized to receive either Cognitive Behavioral Therapy or a low FODMAP diet for a 3-week treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cognitive Behavioral Therapy
- Low FODMAP Diet
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
University of Washington
Collaborator