CBT + Low FODMAP Diet for IBS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether cognitive behavioral therapy (CBT) or a low FODMAP diet benefits children with irritable bowel syndrome (IBS) or functional abdominal pain more. Simple tests will identify which treatment might work best for each child. Children aged 7-12 who frequently experience stomach pain without an identifiable medical cause may be suitable candidates. Participants will either undergo CBT or follow the low FODMAP diet to assess which approach reduces their symptoms. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding effective treatments for children's abdominal pain.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have been treated with antibiotics or probiotics in the last two months, you would not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Cognitive Behavioral Therapy (CBT) and the low FODMAP diet are generally safe and well-tolerated. CBT, a type of talk therapy, helps people change negative thinking patterns. It is widely used and has a strong safety record for various conditions, including irritable bowel syndrome (IBS).
For the low FODMAP diet, studies have shown it reduces symptoms in people with IBS. This diet involves consuming foods low in certain carbohydrates that can cause bloating and discomfort. Research indicates that following this diet for 12 weeks does not lead to major nutritional issues. It is also recommended as a first choice for managing IBS symptoms through diet.
Overall, extensive studies have deemed both treatments safe for people to try.12345Why are researchers excited about this trial?
Researchers are excited about combining Cognitive Behavioral Therapy (CBT) with a low FODMAP diet for IBS because this approach tackles both the psychological and dietary aspects of the condition. While standard treatments often focus on medication to relieve symptoms, this combination offers a holistic strategy by addressing stress and anxiety through CBT and reducing digestive discomfort with a tailored diet. This dual approach could lead to improved symptom management and overall quality of life for IBS sufferers, setting it apart from traditional treatments that may only target one dimension of the condition.
What evidence suggests that this trial's treatments could be effective for IBS?
This trial will compare Cognitive Behavioral Therapy (CBT) with the Low FODMAP diet for managing Irritable Bowel Syndrome (IBS). Research has shown that CBT effectively reduces IBS symptoms, often leading to significant and lasting improvements. One study found that CBT outperformed usual care in easing IBS symptoms. Meanwhile, the Low FODMAP diet has proven effective for many with IBS, with up to 86% of patients reporting reduced abdominal pain and bloating. This diet involves avoiding certain foods that are difficult to digest and can cause discomfort. Both treatments have strong evidence supporting their effectiveness in managing IBS symptoms.678910
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
Exclusion Criteria
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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