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Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children

NCT02360696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2019-05-16

No results posted yet for this study

Summary

Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response.

There are a number of factors that have the potential to contribute to the observed variability in response to montelukast. These include variability in:

1. systemic drug exposure (drug absorption, biotransformation and/or elimination)
2. regulation of leukotriene biosynthesis
3. cysteinyl leukotriene receptors and downstream mediators
4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease classification, psychologic profile)

In this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. The overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.

Conditions

  • Eosinophilia
  • Dyspepsia

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Craig A. Friesen, MD · Children's Mercy, Division of Gastroenterlogy, Hepatology, and Nutrition

  • Steven Leeder, PharmD, PhD · Children's Mercy, Division of Clinical Pharmacology and Medical Toxicology

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360696 on ClinicalTrials.gov