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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
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Lindsay Marie Moye, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Diagnostic Test: Plasma and urine metabolomics

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.


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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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.




Primary Outcome Measures :
  1. Plasma and urine metabolomics [ Time Frame: baseline ]
    parts per million


Biospecimen Retention:   Samples With DNA
Peripheral venous blood, urine, esophageal mucosa biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children ages 2-18 years already undergoing upper endoscopy (EGD)
Criteria

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).

Information from the National Library of Medicine

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


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Baylor College of Medicine
Investigators
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Study Director: Jon M Rhoads, MD The University of Texas Health Science Center, Houston

Publications:

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Responsible Party: Lindsay Marie Moye, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03107819     History of Changes
Other Study ID Numbers: HSC-MS-16-1078
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lindsay Marie Moye, The University of Texas Health Science Center, Houston:
Plasma metabolomics
Urinary metabolomics
Metabonomics
Biomarker discovery

Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases