Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| End Date: | July 2016 |
| Contact: | Nancy E. Lathrom, CCRC |
| Email: | nelathrom@cmh.edu |
| Phone: | 816.855.1860 |
Predictors of Clinical Response to Montelukast in Children With Functional Dyspepsia
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.
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.
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
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