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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Pavia
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Pavia, Pavia, Italia, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Ta kontakt med:
- Antonio Di Sabatino, Medicine
- Telefonnummer: 0382 502973
- E-post: a.disabatino@smatteo.pv.it
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Ta kontakt med:
- Carlo Rossi, Medicine
- Telefonnummer: 00390382502842
- E-post: ca.rossi@smatteo.pv.it
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Pavia, Pavia, Italia, 27100
- Rekruttering
- S. C. General Medicine I, Fondazione IRCCS Policlinico San MAtteo
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Ta kontakt med:
- Carlo Rossi, Medicine
- Telefonnummer: 00390382502842
- E-post: ca.rossi@smatteo.pv.it
-
Ta kontakt med:
- Antonio Di Sabatino, Medicine
- Telefonnummer: 00390382502973
- E-post: a.disabatino@smatteo.pv.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Adult cohort
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Paediatric cohort
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P_473
Legemiddel- og utstyrsinformasjon, studiedokumenter
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