CBT + Low FODMAP Diet for IBS

Recruiting at 1 trial location

Overseen By Cynthia A. Boutte, BSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Bowel surgery, Crohn's, Diabetes, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

250 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Robert J. Shulman, MD

Principal Investigator

Baylor College of Medicine

Rona Levy, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

Parents and children must speak and understand English because of the psychological assessment and CBT requirements

My child is 7-12 years old with stomach pain not caused by a physical illness.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children are randomized to receive either Cognitive Behavioral Therapy or a low FODMAP diet for a 3-week treatment period

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Low FODMAP Diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Low FODMAP diet Experimental Treatment 1 Intervention

Low FODMAP diet

Group II: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+