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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005080
Other study ID # 16-007265
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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