Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome; Functional Bowel Disorder; Functional Abdominal Pain Disorders; Functional Abdominal Pain Syndrome; Functional Abdominal Pain; Functional Gastrointestinal Disorders
• Interventions: Other: Cognitive Behavioral Therapy; Other: Low FODMAP Diet

• Registration Number: NCT03823742
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed 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: 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.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2019-02-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• A child 7-12 years of age with a FGID will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the pediatric Rome III criteria (Rome IV will be substituted when validated). Parents and children must speak and understand English because of the psychological assessment and CBT requirements.

Exclusion Criteria

• Children who have: had past bowel surgery; documented GI disorders (e.g., Crohn's disease); a serious chronic medical condition (e.g., diabetes); weight and/or height < 2 SD for age; chronic conditions with GI symptoms (e.g., cystic fibrosis); autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on gut microbiome analysis), and children who for some reason could not be randomized to the low FODMAP diet.Vegetarian; children who are currently on the FODMAP Diet or receiving CBT Children who speak only Spanish are not eligible because the Rome questionnaire and psychological testing are not available in Spanish. Despite this, a large proportion of the children enrolled will be Hispanic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy
Low FODMAP diet	Low FODMAP Diet	Low FODMAP diet

Primary Outcome Measures

Name	Time	Method
Symptom Improvement	3 to 4 weeks	Abdominal pain frequency or severity

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life	6 months	PedsQL or Functional Disability
Symptom Improvement	6 months	Abdominal pain frequency or severity

Trial Locations

Locations (2)

Children's Nutrition Research Center; 🇺🇸 Houston, Texas, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States