Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease
The Utility of Pharmacogenetic Testing in Managing Children With Persistent Gastroesophageal Reflux Disease Despite Therapy
1 other identifier
observational
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 9, 2019
April 1, 2019
1 year
December 23, 2016
April 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of subjects who change medication due to pharmacogenomic results
12 weeks
Number of subjects who have a repeat scope
12 weeks
Eligibility Criteria
Children \<18 years of age
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Imad Absah, M.D.
Study Record Dates
First Submitted
December 23, 2016
First Posted
December 29, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
October 1, 2018
Last Updated
April 9, 2019
Record last verified: 2019-04