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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823742
• Other study ID #: H-43391
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: Robert J. Shulman, MD
• Phone: 713 798-7178
• Email: rshulman[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Digestive System Diseases
• Functional Abdominal Pain
• Functional Abdominal Pain Disorders
• Functional Abdominal Pain Syndrome
• Functional Bowel Disorder
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome
• Pain
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Cognitive Behavioral Therapy
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 .
• Low FODMAP Diet
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.

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in quality of life	PedsQL or Functional Disability	3 to 4 weeks
Primary	Symptom Improvement	Abdominal pain frequency or severity	3 to 4 weeks
Secondary	Improvement in quality of life	PedsQL or Functional Disability	3 months
Secondary	Symptom Improvement	Abdominal pain frequency or severity	3 months
Secondary	Improvement in quality of life	PedsQL or Functional Disability	6 months
Secondary	Symptom Improvement	Abdominal pain frequency or severity	6 months