Irritable Bowel SyndromeNCT03823742
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
A study testing Cognitive Behavioral Therapy and Low FODMAP Diet in people with Irritable Bowel Syndrome and Functional Abdominal Pain Syndrome, run by Baylor College of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders
- What is being tested?
- Cognitive Behavioral Therapy and Low FODMAP Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2019to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Nutrition Research Center
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Functional Bowel Disorder, Functional Abdominal Pain, Functional Abdominal Pain Disorders
- Being tested
- Cognitive Behavioral Therapy, Low FODMAP Diet
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy Receives: Other: Cognitive Behavioral Therapy |
| Low FODMAP diet | Experimental | Low FODMAP diet Receives: Other: Low FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Improvement
Abdominal pain frequency or severity
Measured: 3 to 4 weeks
Secondary outcomes (4)
Improvement in quality of life
PedsQL or Functional Disability
Measured: 3 months
Symptom Improvement
Abdominal pain frequency or severity
Measured: 3 months
Improvement in quality of life
PedsQL or Functional Disability
Measured: 6 months
Symptom Improvement
Abdominal pain frequency or severity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start22 Feb 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Robert Shulman, M.D., Baylor College of Medicine
- Investigators
- Robert J. Shulman, MD, Principal investigator, Baylor College of MedicineRona Levy, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823742
- Sponsor's protocol ID
- H-43391
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No