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

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.

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Key information

Conditions

Eosinophilia Dyspepsia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ages 8 - 17 years, inclusive
Abdominal pain of at least 8 weeks duration and fulfilling symptom- based criteria for functional dyspepsia
Scheduled for endoscopy following failure to respond to acid-reduction therapy
Evidence of written parental permission (consent) and subject assent

Exclusion criteria

Previous treatment with montelukast
Treatment with corticosteroids or oral cromolyn sodium in the four weeks prior to enrollment
Prior history or clinical signs/symptoms of chronic disease requiring regular medical care (e.g., diabetes mellitus, juvenile idiopathic arthritis, cystic fibrosis or cancer)
Exposure within the past two weeks to drugs or natural products that induce CYP2C8/9 or CYP3A4, including amprenavir, carbamazepine, lopinavir/ritonavir, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, St. John's Wort, or that inhibit CYP2C8/9 or CYP3A4, such as ciprofloxacin, clarithromycin, erythromycin, fluconazole, fluvoxamine, grapefruit juice, paroxetine, sertraline, sulfamethoxazole, trimethoprim
A Body Mass Index of 30 or greater
Non-English speaking
Those patients who will turn 18 during the duration of the study

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Predictors of Clinical Response to Montelukast in Children With Functional Dyspepsia

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Feb 11, 2015
Registry last updated: May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed