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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Low FODMAP Diet
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Nutrition Research CenterRecruiting
  • Texas Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive Behavioral Therapy

Low FODMAP diet

Arm Description

Cognitive Behavioral Therapy

Low FODMAP diet

Outcomes

Primary Outcome Measures

Symptom Improvement
Abdominal pain frequency or severity

Secondary Outcome Measures

Improvement in quality of life
PedsQL or Functional Disability
Symptom Improvement
Abdominal pain frequency or severity
Improvement in quality of life
PedsQL or Functional Disability
Symptom Improvement
Abdominal pain frequency or severity

Full Information

First Posted
January 29, 2019
Last Updated
February 13, 2023
Sponsor
Baylor College of Medicine
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03823742
Brief Title
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Official Title
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Functional Bowel Disorder, Functional Abdominal Pain, Functional Abdominal Pain Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy
Arm Title
Low FODMAP diet
Arm Type
Experimental
Arm Description
Low FODMAP diet
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Low FODMAP Diet
Intervention Description
Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.
Primary Outcome Measure Information:
Title
Symptom Improvement
Description
Abdominal pain frequency or severity
Time Frame
3 to 4 weeks
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
PedsQL or Functional Disability
Time Frame
3 months
Title
Symptom Improvement
Description
Abdominal pain frequency or severity
Time Frame
3 months
Title
Improvement in quality of life
Description
PedsQL or Functional Disability
Time Frame
6 months
Title
Symptom Improvement
Description
Abdominal pain frequency or severity
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Improvement in quality of life
Description
PedsQL or Functional Disability
Time Frame
3 to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert J. Shulman, MD
Phone
713 798-7178
Email
rshulman@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia A. Boutte, BSN
Phone
713 798-7178
Email
cboutte@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Shulman, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rona Levy, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia A. Boutte
Phone
713-798-7178
Email
cboutte@bcm.edu
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia A. Boutte
Phone
713-798-7178
Email
cboutte@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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