Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Gastroesophageal Reflux Clinical Trial

Official title:

Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069573
• Other study ID #: CAAE-36787714.0.0000.5152
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Gastroesophageal Reflux

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. — View Citation

Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22. — View Citation

Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7. Review. — View Citation

Singla MB, Chehade M, Brizuela D, Maydonovitch CL, Chen YJ, Riffle ME, Achem SR, Moawad FJ. Early Comparison of Inflammatory vs. Fibrostenotic Phenotype in Eosinophilic Esophagitis in a Multicenter Longitudinal Study. Clin Transl Gastroenterol. 2015 Dec 17;6:e132. doi: 10.1038/ctg.2015.62. — View Citation

Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009 Oct;49(4):498-547. doi: 10.1097/MPG.0b013e3181b7f563. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis	Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains	2016 August - 2017 March and 2018 November-December
Secondary	Endoscopic features of EoE	Evaluation of the EREFS 'ability (endoscopic reference score) to identify EoE patients and the inflammatory or fibrosis phenotype	2017 January-March and 2018 November-December
Secondary	Symptoms of active EoE	Evaluation of the symptom score's ability to identify EoE patients in active disease	2017 January-March and 2018 November-December
Secondary	Histological features of EoE	Evaluation of the histologic score's ability to identify EoE patients and the inflammatory or fibrosis phenotype	2017 January-March and 2018 November-December