Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005080
• Other study ID #: 16-007265
• Status: Completed
• Start date: December 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who change medication due to pharmacogenomic results		12 weeks
Primary	Number of subjects who have a repeat scope		12 weeks

External Links

•   Mayo Clinic Clinical Trials