Do Biomarkers Predict Response to a Pediatric Chronic Pai... | NCT03823742

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

NCT03823742

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Mar 24, 2026Actual

Enrollment

163Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Functional Abdominal Pain Syndrome
Functional Gastrointestinal Disorders
Functional Bowel Disorder
Functional Abdominal Pain
Functional Abdominal Pain Disorders

Interventions

Cognitive Behavioral Therapy
Low FODMAP Diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2019Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Jan 29, 2019

First Submission Date that Met QC Criteria

Jan 29, 2019

First Posted Date

Jan 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Name	Class
University of Washington	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Behavioral Therapy	Experimental	Cognitive Behavioral Therapy	Other: Cognitive Behavioral Therapy
Low FODMAP diet	Experimental	Low FODMAP diet	Other: Low FODMAP Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy	Other	Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom Improvement	Abdominal pain frequency or severity	3 to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement in quality of life	PedsQL or Functional Disability	3 months
Symptom Improvement	Abdominal pain frequency or severity

Other Outcomes

Measure	Description	Time Frame
Improvement in quality of life	PedsQL or Functional Disability	3 to 4 weeks

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J. Shulman, MD	Baylor College of Medicine	Principal Investigator
Rona Levy, PhD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Nutrition Research Center		Houston	Texas	77030	United States
Texas Children's Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention 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.

ID	Term
D043183	Irritable Bowel Syndrome
D005767	Gastrointestinal Diseases

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D004066	Digestive System Diseases

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D000092724	Elimination Diets
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena