Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population
Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population: a Multicentric Prospective Study in Italy
Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.
Symptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pavia
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Pavia, Pavia, Italia, 27100
- Reclutamiento
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Contacto:
- Antonio Di Sabatino, Medicine
- Número de teléfono: 0382 502973
- Correo electrónico: a.disabatino@smatteo.pv.it
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Contacto:
- Carlo Rossi, Medicine
- Número de teléfono: 00390382502842
- Correo electrónico: ca.rossi@smatteo.pv.it
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Pavia, Pavia, Italia, 27100
- Reclutamiento
- S. C. General Medicine I, Fondazione IRCCS Policlinico San MAtteo
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Contacto:
- Carlo Rossi, Medicine
- Número de teléfono: 00390382502842
- Correo electrónico: ca.rossi@smatteo.pv.it
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Contacto:
- Antonio Di Sabatino, Medicine
- Número de teléfono: 00390382502973
- Correo electrónico: a.disabatino@smatteo.pv.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patients with an established diagnosis of Eosinophilic esophagitis;
- aged ≥5 years;
- who gave written informed consent.
Exclusion Criteria:
- under 5 years old;
- Patients who are illiterate;
- Patients who are unwilling to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Adult cohort
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Paediatric cohort
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluate the repeatability (test-retest reliability) of the Italian version of DSQ questionnaire at enrollment and at 1 months afterwards.
Periodo de tiempo: 1 months afterwards the enrollment
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The Intraclass correlation coefficient (ICC) will be calculated to evaluate the test-retest reliability of the Italian version of DSQ questionnaire.
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1 months afterwards the enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.
Periodo de tiempo: every year for 5 years total
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To calculate the cumulative proportion of maintenance of remission in the follow-up period will be estimated using Kaplan-Meier failure estimator both in EoE adult and paediatric patients.
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every year for 5 years total
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Eosinofilia
- Trastornos de los leucocitos
- Enfermedades hematológicas
- Enfermedades esofágicas
- Gastroenteritis
- Esofagitis
- Enfermedades hemic y linfáticas
- Esofagitis eosinofílica
Otros números de identificación del estudio
- P_473
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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