Public trial
RBR-2ntbth9 Assessment of response to antacids in children with Eosinophilic Esophagitis
Date of registration: 01/29/2024 (mm/dd/yyyy)Last approval date : 01/29/2024 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Evaluation of response to proton pump inhibitors in pediatric patients with Eosinophilic Esophagitis
pt-br
Avaliação da resposta aos inibidores de bomba de protons em pacientes pediátricos com Esofagite Eosinofilica
es
Evaluation of response to proton pump inhibitors in pediatric patients with Eosinophilic Esophagitis
Trial identification
- UTN code: U1111-1301-1842
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Public title:
en
Assessment of response to antacids in children with Eosinophilic Esophagitis
pt-br
Avaliação da resposta com Antiácidos em crianças com Esofagite Eosinofilica
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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4.764.683
Issuing authority: Comitê de Ética em Pesquisa do Hospital da Criança Santo Antônio
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44070821.9.0000.5683
Issuing authority: Plataforma Brasil
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4.764.683
Sponsors
- Primary sponsor: Hospital Santa Casa de Misericórdia de Porto Alegre
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Secondary sponsor:
- Institution: Hospital Santa Casa de Misericórdia de Porto Alegre
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Supporting source:
- Institution: Hospital Santa Casa de Misericórdia de Porto Alegre
Health conditions
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Health conditions:
en
Eosinophilic Esophagitis
pt-br
Esofagite Eosinofílica
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General descriptors for health conditions:
en
k20 Esophagitis
pt-br
k20 Esofagite
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Specific descriptors:
en
C06.405.117.620.209 Eosinophilic Esophagitis
pt-br
C06.405.117.620.209 Esofagite Eosinofílica
Interventions
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Interventions:
en
Clinical, prospective, open trial study. A total of 27 patients with the diagnosis of Eosinophilic Esophigitis were included. After the diagnosis, All of the patients received treatment with proton pump inhibitor (esomeprazole or omeprazole), at a dose of 1mg/kg per dose twice daily, orally, for 8-12 weeks. After this period, the endoscopy was repeated. Both patients and researchers knew that patients were taking the medication.
pt-br
Ensaio clínico, prospectivo, aberto. Um total de 27 pacientes foram incluidos que tinham diagnostico de esofagite eosinofilia. Após o diagnóstico, todos os pacientes receberam tratamento com inibidores de bomba de protons (esomeprazol ou omeprazol) na dose de 1mk/kg/dose, duas vezes por dia, via oral, por 8 a 12 semanas. Após este período, a endoscopia foi repetida. Tanto os pacientes quanto os pesquisadores sabiam que os pacientes estavam recebendo a medicação.
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Descriptors:
en
D27.505.519.389.848 Proton Pump Inhibitors
pt-br
D27.505.519.389.848 Inibidores da Bomba de Prótons
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 05/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 27 - 0 18 Y -
Inclusion criteria:
en
Children and Adolescents aged 1month to 18 years who were referred to the pediatric endoscopy unit were included. Patients were included when they met the diagnosis criteria for Eosinophilic esophagitis (presenting at least one symptom of esophageal dysfunction; esophageal biopsy with more than 15 eosinophil per high power field) and absence of gastric and duodenal eosinophilia. 4 to 6 biopsies were randomly obtained from the distal and middle esophagus. Biopsies specimens were also obtained from the antrum and duodenum to exclude gastritis and eosinophilic gastroenteritis
pt-br
Foram incluídos consecutivamente crianças e adolescentes de 1 mês a 18 anos que eram referidos para a unidade de endoscopia pediátrica deste hospital em Porto Alegre. Foram incluídos pacientes quando fecharem os critérios diagnósticos para Esofagite Eosinofílica (apresentarem pelo menos um sintoma de disfunção esofágica; biópsia de esôfago com mais de 15 eosinófilos por campo de grande aumento e ausência de eosinofilia gástrica e duodenal)
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Exclusion criteria:
en
Children were excluded if they had received prior and recent (up to 1 month before the endoscopy) treatment with proton pump inhibitor; corticosteroids or elimination diet; or if they presented duodenal or gastric eosinophilia or viral, fungal or caustic esophagitis
pt-br
Tratamento prévio e recente (até 1 mês antes) com inibidor de bomba de protons; esteroides orais e/ou dieta de eliminação; presença de eosinofilia duodenal e/ou gástrica ou outras causas de esofagite como esofagite viral, fúngica ou cáustica
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Single-group 1 Open Single-arm-study 4
Outcomes
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Primary outcomes:
en
It is expected to find a therapeutic response in pediatric patients with eosinophilic esophagitis who received proton pump inhibitor medication
pt-br
Espera-se encontrar uma resposta terapêutica nos pacientes pediátricos com esofagite eosinofílica que receberam o medicamento inibidor de bomba de prótons
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Secondary outcomes:
en
It is expected to find demographic associations in pediatric patients with eosinophilic esophagitis that received proton pump inhibitors medication. Its is expected to find clinical, endoscopic and histological associations in pediatric patients with eosinophilic esophagitis who received proton pump inhibitor medication
pt-br
Espera-se encontrar associações demográficas em pacientes pediátricos com esofagite eosinofílica que receberam o medicamento inibidor da bomba de prótons. Espera-se encontrar associações clínicas, endoscópicas e histológicas em pacientes pediátricos com esofagite eosinofílica que receberam o medicamento inibidor de bomba de prótons
Contacts
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Public contact
- Full name: Luiza Salgado Nader
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- Address: Professor Annes Dias, 135, centro histórico
- City: Porto Alegre / Brazil
- Zip code: 90020090
- Phone: +555132148000
- Email: luizasnader@gmail.com
- Affiliation: Hospital Santa Casa de Misericórdia de Porto Alegre
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Scientific contact
- Full name: Luiza Salgado Nader
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- Address: Professor Annes Dias, 135, centro histórico
- City: Porto Alegre / Brazil
- Zip code: 90020090
- Phone: +555132148000
- Email: luizasnader@gmail.com
- Affiliation: Hospital Santa Casa de Misericórdia de Porto Alegre
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Site contact
- Full name: Luiza Salgado Nader
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- Address: Professor Annes Dias, 135, centro histórico
- City: Porto Alegre / Brazil
- Zip code: 90020090
- Phone: +555132148000
- Email: luizasnader@gmail.com
- Affiliation: Hospital Santa Casa de Misericórdia de Porto Alegre
Additional links:
Total de Ensaios Clínicos 16912.
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