Metabolomics for Biomarker Discovery in Children With EoE

April 30, 2018 updated by: Lindsay Marie Moye, The University of Texas Health Science Center, Houston

Plasma and Urine Metabolomics for Biomarker Discovery in Children With Eosinophilic Esophagitis

The investigators are seeking to enroll 8 children ages 2-18 already undergoing upper endoscopy. For the purposes of research, a peripheral blood and clean catch urine specimen will be obtained to measure plasma and urine metabolomics. The data will be used to determine if there are any key differences in the metabolite profile of subjects found to have eosinophilic esophagitis (EoE) versus non-EoE subjects. Once these metabolites are identified, the investigators will seek to enroll many more subjects for a validation phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

24

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
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

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

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children ages 2-18 years already undergoing upper endoscopy (EGD)

Description

Inclusion Criteria:

  1. Pediatric patients, ages 2-18 years, undergoing EGD with biopsies of the esophagus.
  2. Children with known EoE will only be enrolled if his/her biopsy on the day of specimen collection demonstrates ≥15 eosinophils (eos) per high power field (hpf).

Exclusion Criteria:

  1. Presence of other disorders associated with similar clinical, histological or endoscopic features, such as proton pump inhibitor (PPI)-responsive esophageal eosinophilia, esophageal eosinophilia associated with gastroesophageal reflux, Crohn's disease, infectious esophagitis (i.e. herpes simplex virus or candida), drug-associated esophagitis, collagen vascular disease, hypereosinophilic syndrome and eosinophilic gastroenteritis.
  2. Children with known EoE and biopsy demonstrating <15 eos/hpf at the time of specimen collection.
  3. Inability to provide a clean catch urine specimen (i.e. not toilet-trained).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma and urine metabolomics
Time Frame: baseline
parts per million
baseline

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Baylor College of Medicine

Investigators

  • Study Director: Jon M Rhoads, MD, The University of Texas Health Science Center, Houston

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.

General Publications

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 (Actual)

March 29, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-16-1078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Eosinophilic Esophagitis

Clinical Trials on Plasma and urine metabolomics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe