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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
- ClinicalTrials.gov ID
- NCT03823742
- Acronym / sponsor ID
- H-43391
- Conditions
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Functional Bowel Disorder, Functional Abdominal Pain, Functional Abdominal Pain Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Other: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
| Low FODMAP diet | Experimental | Other: Low FODMAP DietLow FODMAP diet |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive 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 . | Other | Cognitive Behavioral Therapy |
| Low FODMAP DietLow 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. | Other | Low FODMAP diet |
Primary outcome
Symptom Improvement
Time frame: 3 to 4 weeks
Abdominal pain frequency or severity
4 secondary outcomes
Improvement in quality of life
Time frame: 3 months
Symptom Improvement
Time frame: 3 months
Improvement in quality of life
Time frame: 6 months
Symptom Improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Shulman, MD principal investigator
Baylor College of Medicine
Rona Levy, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Improvement (time frame: 3 to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.