RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-02-22

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03823742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Robert J. Shulman, MD

CONTACT

713 798-7178

rshulman@bcm.edu

Cynthia A. Boutte, BSN

CONTACT

713 798-7178

cboutte@bcm.edu

Principal Investigator

Robert J. Shulman, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Rona Levy, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

Children's Nutrition Research Center

Houston, Texas, 77030

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Robert J. Shulman, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine
Rona Levy, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-22

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-02-22

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

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