Clinical trial NCT03823742: 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
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Functional Abdominal Pain Syndrome
Functional Gastrointestinal Disorders
Functional Bowel Disorder
Functional Abdominal Pain
Functional Abdominal Pain Disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2019-01-30
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptom Improvement
timeFrame: 3 to 4 weeks
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 3 months
measure: Symptom Improvement
timeFrame: 3 months
measure: Improvement in quality of life
timeFrame: 6 months
measure: Symptom Improvement
timeFrame: 6 months
Other outcomes:
measure: Improvement in quality of life
timeFrame: 3 to 4 weeks
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Robert J. Shulman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Rona Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References: