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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Predictors of Clinical Response to Montelukast in Children With Functional Dyspepsia

Brief 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.


Detailed Summary:
Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome: Identification of a signature of montelukast response using gene expression patterns in biopsy samples from clinical responders and non-responders to montelukast. [ Time Frame: Approximately 7-8 weeks ]

Identification of patients who will benefit from montelukast therapy , allowing more efficient, and possibly more effective, care.


Original Primary Outcome: Same as current

Current Secondary Outcome: Characterization a signature of montelukast response using comparison gene expression patterns in biopsy samples obtained before and after montelukast therapy in children with a positive clinical response to the drug. [ Time Frame: 7-8 weeks. ]

Identification and development of a signature of montelukast response applied to eosinophilic gastroenteritis, and more generally to other diseases, such as asthma, where the drug is widely used with variable success.


Original Secondary Outcome: Same as current

Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: September 3, 2014
Date Started: August 2014
Date Completion: July 2016
Last Updated: February 5, 2015
Last Verified: February 2015