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CBT + Low FODMAP Diet for IBS

N/A
Recruiting
Led By Robert J. Shulman, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Children who have had past bowel surgery
Children with documented GI disorders (e.g., Crohn's disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether biomarkers can predict which children with IBS will respond better to CBT or the low FODMAP diet.

Who is the study for?
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.
What is being tested?
The study aims to determine if certain biomarkers can predict whether a child would benefit more from Cognitive Behavioral Therapy (CBT) or a Low FODMAP Diet for managing symptoms of pediatric chronic pain associated with gastrointestinal issues.
What are the potential side effects?
While not medication-based interventions, side effects may include discomfort from dietary changes in the low FODMAP diet group and emotional distress during cognitive behavioral therapy sessions as children learn to manage their pain.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child has had surgery on their intestines before.
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My child has a diagnosed GI disorder like Crohn's disease.
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My child has a serious long-term illness like diabetes.
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My child does not speak only Spanish.
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My child is significantly under the average height or weight for their age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Symptom Improvement
Other study objectives
Improvement in quality of life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low FODMAP dietExperimental Treatment1 Intervention
Low FODMAP diet
Group II: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Cognitive Behavioral Therapy

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,319 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,029,912 Total Patients Enrolled
Robert J. Shulman, MDPrincipal InvestigatorBaylor College of Medicine
Rona Levy, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03823742 — N/A
Functional Abdominal Pain Disorder Research Study Groups: Cognitive Behavioral Therapy, Low FODMAP diet
Functional Abdominal Pain Disorder Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT03823742 — N/A
Cognitive Behavioral Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03823742 — N/A
~0 spots leftby Dec 2024
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