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Updated: May 15, 2025
Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
Protocol for a Randomized Controlled Trial to Determine if Biomarkers Predict Response to a Pediatric Chronic Pain
Rona L Levy1, Tasha B Murphy1, Margaret M Heitkemper2
1School of Social Work, University of Washington, Seattle, WA 98195, USA.
Insights
This study investigates personalized treatments for children with disorders of gut-brain interaction (DGBI). Identifying physiological biomarkers may predict whether cognitive behavioral therapy (CBT) or a low FODMAP diet (LFD) is more effective for abdominal pain relief.
Area of Science:
- Pediatric gastroenterology
- Neurogastroenterology
- Biomedical research
Background:
- Disorders of Gut-Brain Interaction (DGBI) affect 15-20% of children and adults, causing chronic abdominal pain and disability.
- Current management strategies like cognitive behavioral therapy (CBT) and the low FODMAP diet (LFD) show limited efficacy, improving symptoms in only ~40% of patients.
- Biomarkers and gut microbiome composition may influence treatment response, but this has not been studied in pediatric DGBI trials.
Purpose of the Study:
- To identify physiological characteristics that predict differential treatment response to CBT versus LFD in children with DGBI.
- To compare the effectiveness of CBT and LFD in children with and without specific abnormal physiological biomarkers.
- To optimize management strategies for DGBI by matching interventions to individual patient profiles.
Main Methods:
- A randomized controlled trial involving 200 children aged 7-12 years with DGBI.
- Categorization of participants based on Autonomic Nervous System imbalance and/or gut physiology abnormalities.
- Randomization to either CBT or LFD to assess treatment effectiveness in relation to identified physiological biomarkers.
Main Results:
- The study hypothesizes that CBT will be more effective in children without abnormal physiology, while LFD will be more effective in those with abnormal physiology.
- Primary outcomes include improvements in abdominal pain frequency/severity and health-related quality of life.
- This study is the first to link physiological biomarkers to treatment response in pediatric DGBI.
Conclusions:
- This research pioneers the identification of physiological moderators for DGBI treatment.
- Findings may enable personalized medicine approaches, improving outcomes for children with chronic abdominal pain.
- Timely application of the most effective intervention based on individual characteristics can reduce the burden of DGBI.
Abstract:
Background/Objectives: Disorders of gut-brain interaction (DGBI), characterized by chronic abdominal pain and significant disability, affect 15-20% of children and adults and continue into adulthood in ~60% of cases. Costs for adults reach USD 30 billion per year, yet effective management strategies are elusive. Studies support using cognitive behavioral therapy (CBT), but abdominal pain only improves in ~40% of patients. Dietary management (low FODMAP diet; LFD) has also shown promise but it is effective in only a similar percentage of patients. Studies suggest that biologic factors (biomarkers) contribute to CBT response. Similarly, gut microbiome composition appears to influence abdominal pain response to the LFD. However, no previous CBT trials in children or adults have measured these biomarkers, and it is unclear which patients respond best to CBT vs. LFD. Methods: Children aged 7-12 years with DGBIs (n = 200) will be categorized as having/not having Autonomic Nervous System imbalance and/or abnormalities in gut physiology. We will randomize these children to either CBT or a LFD to compare the effectiveness of these treatments in those with/without abnormal physiologic biomarkers. We hypothesize that CBT will be more effective in those without abnormal physiology and LFD will be more effective in children with abnormal physiology. Primary outcome measures include the following: (1) Symptom improvement (abdominal pain frequency/severity) and (2) improvement in health-related quality of life. Conclusions: This innovative multidisciplinary study is the first to identify physiological characteristics that may moderate the response to two different management strategies. Identification of these characteristics may reduce the burden of these disorders through timely application of the intervention most likely to benefit an individual patient.
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