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Studio clinico pilota: utilizzo di una nuova formulazione di Budesonide Viscosa in bambini con Esofagite Eosinofila - BUDEOE

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512395-36-00
Acronym
BUDEOE
Enrollment
10
Registered
2024-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

Reduction/disappearance of eosinophil count in oesophageal mucosa (<15 EoE/HPF) after viscous budesonide therapy (T12)

Detailed description

Reduction of the symptomatic score calculated after therapy (T12), Reduction in endoscopic score calculated after therapy (T12), Monitoring and collection of adverse events (AEs) and severe adverse events (SAEs) (T6; T12)

Interventions

DRUGBUDESONIDE

Sponsors

University Hospital Consorziale Policlinico, University Of Bari Aldo Moro
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Reduction/disappearance of eosinophil count in oesophageal mucosa (<15 EoE/HPF) after viscous budesonide therapy (T12)

Secondary

MeasureTime frame
Reduction of the symptomatic score calculated after therapy (T12), Reduction in endoscopic score calculated after therapy (T12), Monitoring and collection of adverse events (AEs) and severe adverse events (SAEs) (T6; T12)

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026