Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease

April 5, 2019 updated by: Imad Absah, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children <18 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-007265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe