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Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Study Purpose

The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose

Exclusion Criteria:

- Pediatric patients who are undergoing upper gastrointestinal endoscopy for therapeutic procedures - The presence of other eosinophilic diseases - Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03069573
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federal University of Uberlandia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Luiz Ricardo Goulart, ProfessorCristina P Barros, Professor
Principal Investigator Affiliation Federal University of UberlandiaFederal University of Uberlandia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis, Gastroesophageal Reflux
Additional Details

This study collects clinical information from pediatric patients between 0-18 years old who have been undergoing upper gastrointestinal endoscopy due to general complaints. The demographic, clinical symptoms, endoscopy, pH monitoring, and histology data are assessed during the diagnostic process. In the baseline endoscopy procedure samples (blood, saliva, esophageal tissue, and esophageal mucus) are taken. After diagnostic process of EoE and Gastroesophageal reflux disease (GERD) supported by International Guidelines the patients are divided into three groups

  • - EoE, GERD, and Control.
The techniques are used for patients characterization and assessment: 1. Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0)
  • - translated and adapted version for Brazilian Portuguese 2.
Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) 3. Peak eosinophil count (PEC) and histological features description 4. Proteomic analyses 5. Microbiome analyses 6. Immunohistochemistry analyses

Contact a Trial Team

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International Sites

Federal University of Uberlandia, Uberlândia, Minas Gerais, Brazil

Status

Recruiting

Address

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-902

Site Contact

Cristina P Barros, Professor

cpalmerb@yahoo.com.br

+55 34 32258440

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