# DO BIOMARKERS PREDICT RESPONSE TO A PEDIATRIC CHRONIC PAIN SYMPTOM MANAGEMENT PROGRAM?

> **NIH NIH R01** · BAYLOR COLLEGE OF MEDICINE · 2020 · $585,534

## Abstract

Functional abdominal pain gastrointestinal disorders (FGIDs) affect 15-20% of school age children and
adults in the US and worldwide. FGIDs are characterized by intermittent abdominal pain, often associated with
significant disability. FGIDs continue into adulthood in up to 60% of cases and estimated costs for adults in the
US are near $30 billion per year. Despite the ubiquity of FGIDs and their tremendous international economic,
social, and emotional burden, finding widely effective management strategies has been elusive. Our studies in
children and others in adults support cognitive behavioral therapy (CBT) as our current best strategy to treat
FGIDs but abdominal pain only improves in 40% of patients. Given the expense and time investment required
for CBT, the knowledge gap of which patients are likely to respond best needs to be addressed. More recently,
dietary management (low FODMAP diet) is showing promise but it too, is effective in only 50% of patients.
 Recent studies from our group suggest that biologic factors (measured by biomarkers) play a role in
determining the response to CBT. Similarly, our recent work shows that gut microbiome composition appears
to influence whether abdominal pain will respond to a low FODMAP diet. Despite the potential critical
importance of these highly informative physiologic biomarkers, no CBT trials to date in children or adults have
measured them. Thus, building on our experience to date with CBT and dietary interventions in children with
FGIDs, we propose to categorize children ages 7-12 yrs. of age with FGIDs (n=200) as to whether they
have/do not have one or more of the following abnormal physiologic changes:
 (1) Autonomic Nervous System imbalance as measured by low heart rate variability; and/or (2)
Abnormalities in gut physiology: Impaired gut barrier function (increased permeability); and/or Decreased
abundance of Bacteroides (measured by shotgun metagenomic sequencing); and/or (3) Gut neuroimmune
dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations).
 We propose to randomize these children, stratified by presence/absence of physiologic abnormalities to
CBT or a low FODMAP diet using our previously tested programs and compare the effectiveness of the
treatments in those with/without abnormal physiologic biomarkers. We Hypothesize that CBT will be more
effective in those without abnormal physiology whereas Diet will be more effective in children with abnormal
physiology. Primary outcome measures will be: 1) Symptom improvement (abdominal pain frequency or
severity measured by prospective diary) and 2) Improvement in health related quality of life (PedsQL)
 This innovative multidisciplinary study will be the first addressing the critical need to identify physiological
characteristics that may moderate the response to management, potentially reducing the burden of these
disorders through timely application of the intervention most likely to benefit an individual patient. ...

## Key facts

- **NIH application ID:** 9899324
- **Project number:** 5R01NR016786-03
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Rona L. Levy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $585,534
- **Award type:** 5
- **Project period:** 2018-06-06 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9899324

## Citation

> US National Institutes of Health, RePORTER application 9899324, DO BIOMARKERS PREDICT RESPONSE TO A PEDIATRIC CHRONIC PAIN SYMPTOM MANAGEMENT PROGRAM? (5R01NR016786-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9899324. Licensed CC0.

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