Clinical trial NCT03069573: Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients
Official title: Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Gastroesophageal Reflux
Keywords: Eosinophilic Esophagitis
Gastroesophageal Reflux
Diagnose
Biomarker
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 110
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive pediatric patients undergoing esophagogastroduodenoscopy (due to general complaints) at a Tertiary Public Health Care Center

Brief summary: 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

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis
timeFrame: 2016 August - 2017 March and 2018 November-December
Secondary outcomes:
measure: Endoscopic features of EoE
timeFrame: 2017 January-March and 2018 November-December
measure: Symptoms of active EoE
timeFrame: 2017 January-March and 2018 November-December
measure: Histological features of EoE
timeFrame: 2017 January-March and 2018 November-December
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Luiz Ricardo Goulart, Professor
role: STUDY_DIRECTOR
affiliation: Federal University of Uberlandia
name: Cristina Palmer Barros, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
citation: Aceves SS, Newbury RO, Dohil MA, Bastian JF, Dohil R. A symptom scoring tool for identifying pediatric patients with eosinophilic esophagitis and correlating symptoms with inflammation. Ann Allergy Asthma Immunol. 2009 Nov;103(5):401-6. doi: 10.1016/S1081-1206(10)60359-6.
citation: de Souza TA, Carneiro AP, Narciso AS, Barros CP, Alves DA, Marson LB, Tunala T, de Alcantara TM, de Paiva Maia YC, Briza P, Ferreira F, Goulart LR. Eosinophilic esophagitis auxiliary diagnosis based on a peptide ligand to eosinophil cationic protein in esophageal mucus of pediatric patients. Sci Rep. 2022 Jul 18;12(1):12226. doi: 10.1038/s41598-022-16293-1.