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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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
1,813 Previous Clinical Trials
1,913,569 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,023 Previous Clinical Trials
6,029,031 Total Patients Enrolled
Robert J. Shulman, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has had surgery on their intestines before.Kids who cannot be chosen at random to follow the low FODMAP diet for some reason.My child follows a vegetarian diet.Children with autism, significant delays in development, psychosis, or a history of bipolar disorder are not eligible.My child is 7-12 years old with stomach pain not caused by a physical illness.My child has a diagnosed GI disorder like Crohn's disease.My child has not taken antibiotics or probiotics in the last 2 months.My child has a chronic condition with stomach or bowel symptoms.My child has a serious long-term illness like diabetes.My child does not speak only Spanish.My child is significantly under the average height or weight for their age.My child is currently on the FODMAP Diet or receiving CBT.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy
- Group 2: Low FODMAP diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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