Last reviewed · How we verify
NCT03823742
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
Completed
NA
Last updated 24 March 2026
What this trial tests
NA trial testing Cognitive Behavioral Therapy in Irritable Bowel Syndrome in 163 participants. Completed in 31 December 2025.
Timeline
22 February 2019
Primary endpoint
31 December 2024
31 December 2024
31 December 2025
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 163 |
| Start date | 22 February 2019 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Cognitive Behavioral Therapy
- Low FODMAP Diet
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
- Functional Abdominal Pain Syndrome — all drugs for Functional Abdominal Pain Syndrome →
- Functional Gastrointestinal Disorders — all drugs for Functional Gastrointestinal Disorders →
- Functional Bowel Disorder — all drugs for Functional Bowel Disorder →
Sponsor
Baylor College of Medicine
Who can join
Adults 7 to 12, any sex, with Irritable Bowel Syndrome or Functional Abdominal Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Factors Associated With Adherence to a Low Fermentable Carbohydrate Diet in Children With Functional Gastrointestinal Disorders.
Tenenbaum RB, Czyzewski D, McMeans A, Narayana V, et al · · 2024 · cited 5× · PMID 37683726 · DOI 10.1016/j.jand.2023.09.001 -
Protocol for a Randomized Controlled Trial to Determine if Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program.
Levy RL, Murphy TB, Heitkemper MM, van Tilburg MAL, et al · · 2025 · cited 2× · PMID 40364216 · DOI 10.3390/jcm14093185 -
Relationship Between Heart Rate Variability and Sleep Among Girls and Boys With Abdominal Pain-Related Disorders of Gut-Brain Interaction.
Kamp KJ, Burr RL, Matherne CE, Simonds E, et al · · 2026 · PMID 41873558 · DOI 10.1111/nmo.70293 -
Characterizing fermentable carbohydrate foods in the diets of children with abdominal pain-related disorders of gut-brain interaction and healthy children.
Narayana V, Chang J, McMeans AR, Murphy T, et al · · 2025 · PMID 40333954 · DOI 10.1371/journal.pone.0311589
Verify or expand the search:
- PubMed search for NCT03823742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Baylor College of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03823742 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
- Last refreshed: 24 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03823742.
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