Metabolomics for Biomarker Discovery in Children With EoE
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|ClinicalTrials.gov Identifier: NCT03107819|
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment|
|Eosinophilic Esophagitis||Diagnostic Test: Plasma and urine metabolomics|
Eosinophilic esophagitis (EoE) is a disorder of the esophagus triggered by food and/or environmental allergens and is characterized by symptoms of esophageal dysfunction and eosinophilia of the esophagus. The standard of care for diagnosing and monitoring EoE is with biopsies of the esophagus. There are currently no known biomarkers that correlate with the inflammatory activity of esophageal mucosa, and patients' symptoms alone are insufficient in providing a reliable assessment. Some studies report that patients with EoE may undergo endoscopy up to 11 times in one year. Finding a non-invasive biomarker would therefore be of high clinical and economic interest.
The investigators will seek to enroll 8 children ages 2-18 years already undergoing esophagogastroduodenoscopy (EGD). For the purposes of research, a peripheral blood specimen will be collected at the same time of peripheral intravenous (IV) placement, which is routinely performed for the purposes of sedation during endoscopy, thereby avoiding extra needle sticks. A urine sample will also be collected on the day of the EGD. These specimens will then be analyzed for plasma and urine metabolomics to evaluate for any derangements in EoE versus non-EoE subjects.
Risks to participants undergoing EGD are the same as they would be if they were not enrolled in the study as no additional biopsies will be taken. Risks associated with a blood draw are minimal and include some discomfort, such as lightheadedness, fainting, bruising, soreness, clotting and bleeding at the site of the needle stick, and in rare cases, infection. Collection of the urine specimen is by clean catch in only toilet-trained individuals.
This study should yield valuable information regarding plasma and urine metabolomics in EoE versus non-EoE subjects. Once this "discovery" data set is analyzed, future research could then focus specifically on those abnormal metabolites and seek to enroll many more subjects for a validation phase.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Plasma and Urine Metabolomics for Biomarker Discovery in Children With Eosinophilic Esophagitis|
|Actual Study Start Date :||March 29, 2017|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
Pediatric patients undergoing EGD
Subjects ages 2-18 years undergoing upper endoscopy (EGD) will submit a blood and urine specimen for plasma and urine metabolomics profiling.
Diagnostic Test: Plasma and urine metabolomics
Through the use of high-pressure liquid chromatography and mass spectrometry, quantitative measurements of targeted metabolites associated with amino acids, methylation, acetylation and the tricarboxylic acid (TCA) cycle will be analyzed on the blood and urine specimens.
- Plasma and urine metabolomics [ Time Frame: baseline ]parts per million
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107819
|United States, Texas|
|University of Texas Health Science Center|
|Houston, Texas, United States, 77030|
|Study Director:||Jon M Rhoads, MD||The University of Texas Health Science Center, Houston|