Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients
NCT ID: NCT03069573
Last Updated: 2020-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2015-01-01
2019-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Eosinophilic Esophagitis - EoE
Diagnosis of pediatric EoE under current guidelines.
No interventions assigned to this group
Gastroesophageal reflux disease - GERD
Diagnosis of pediatric GERD under current guidelines.
No interventions assigned to this group
Control
Exclusion diagnosis of EoE or GERD, with non specific gastrointestinal general complaints.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The presence of other eosinophilic diseases
* Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks
18 Years
ALL
No
Sponsors
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Federal University of Uberlandia
OTHER
Responsible Party
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Cristina Palmer Barros
Professor
Principal Investigators
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Luiz Ricardo Goulart, Professor
Role: STUDY_DIRECTOR
Federal University of Uberlandia
Cristina Palmer Barros, Professor
Role: PRINCIPAL_INVESTIGATOR
Federal University of Uberlandia
Locations
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Federal University of Uberlandia
Uberlândia, Minas Gerais, Brazil
Countries
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References
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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.
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.
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.
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(12):e132. doi: 10.1038/ctg.2015.62.
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.
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.
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.
Other Identifiers
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CAAE-36787714.0.0000.5152
Identifier Type: -
Identifier Source: org_study_id
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