Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease

The Utility of Pharmacogenetic Testing in Managing Children With Persistent Gastroesophageal Reflux Disease Despite Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03005080

Enrollment

Registered

2016-12-29

Start date

2016-12-31

Completion date

2018-10-31

Last updated

2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Brief summary

This study will use a 22 gene pharmacogenomics panel on 30 children with persistent Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.

Detailed description

This study will assess the clinical utility of pharmacogenomics testing in the clinical management of children with refractory GERD, despite adequate therapy and the role of pharmacogenomics in selecting the right acid suppressive therapy based on each patient's symptoms and pharmacogenomics results.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* persistent gastrointestinal symptoms (GI) suggestive of gastro esophageal reflux disease (GERD) despite adequate therapy * persistent evidence of abnormal reflux indices' and acid exposure on esophageal multichannel pH impedance study despite adequate therapy * persistent endoscopic evidence of reflux esophageal disease despite adequate therapy

Exclusion criteria

* children with eosinophilic esophagitis diagnosis * children with any esophageal surgical intervention like fundoplication, tracheoespahgeal fistula repair or esophageal atresia repair * children with other diseases that can affect the esophagus, like Crohn's disease or food protein-induced enterocolitis syndrome (F-PIES) * Children who do not have research authorization in their chart

Design outcomes

Primary

Measure	Time frame
Number of subjects who change medication due to pharmacogenomic results	12 weeks
Number of subjects who have a repeat scope	12 weeks

Countries

United States

Outcome results