Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Functional Abdominal Pain
- Functional Abdominal Pain Disorders
- Functional Abdominal Pain Syndrome
- Functional Bowel Disorder
- Functional Gastrointestinal Disorders
- Irritable Bowel Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The proposed study is a randomized trial with a two group design. Children will be equally likely to be randomized to either CBT or a low FODMAP diet. There is no placebo treatment and no healthy controls are to be studied. Subjects will be stratified based on age (7-9 vs 10-12), sex, baseline pain (mean pain frequency: less than or equal to 50% of the rated intervals or > 50% of the rated intervals, as reported on the baseline pain and stool diary) and PedsQL.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 7 years and 12 years
- Gender
- Both males and females
Description
AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities in gut physiology: Imp...
AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities in gut physiology: Impaired gut barrier function (increased permeability); and/or increased abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations). AIM 2: Children will be randomized to the two treatments most commonly used in clinical practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks, 3 months, and 6 months.
Tracking Information
- NCT #
- NCT03823742
- Collaborators
- University of Washington
- Investigators
- Principal Investigator: Robert J. Shulman, MD Baylor College of Medicine Principal Investigator: Rona Levy, PhD University of Washington
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