Studio clinico pilota: utilizzo di una nuova formulazione di Budesonide Viscosa in bambini con Esofagite Eosinofila - BUDEOE
- Conditions
- Eosinophilic Esophagitis
- Registration Number
- 2024-512395-36-00
- Lead Sponsor
- University Hospital Consorziale Policlinico, University Of Bari Aldo Moro
- Brief Summary
Evaluation of the efficacy of the new viscous budesonide suspension in children and adolescents with EoE
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not authorised
- Sex
- Not specified
- Target Recruitment
- 10
Age 4-18 years
Diagnosis of EoE (>15 eosinophils/HPF in oesophageal biopsies) with failure to respond to proton pump inhibitors or with flare-up after discontinuation of proton pump inhibitors. The diagnosis must have been confirmed by endoscopy with oesophageal, gastric and duodenal biopsies. Subjects with a peak intraepithelial eosinophil count of ≥15/HPF (standard size 0.3 mm2) and no significant gastric or duodenal pathology will be histologically eligible for the study
Subjects with previous topical steroid therapy (non-response or flare-up after discontinuation)
Informed written parental/legal representative consent and verbal consent according to the maturity of the child
Female subjects of childbearing age after urine pregnancy test. Sexual abstinence is an acceptable method of contraception, if in line with the subject's normal habits. The use of contraceptive methods will also be required for the duration of the study. Acceptable contraceptive methods are combined low-dose oral hormonal contraceptives; male or female condom with or without spermicide; male condom hood, diaphragm or sponge with spermicide, a combination of male condom with spermicide hood, diaphragm or sponge with spermicide (double barrier)
Presence of other non-EoE gastrointestinal diseases (e.g. eosinophilic gastroenteritis/colitis, chronic inflammatory bowel disease, or coeliac disease)
Use of proton pump inhibitors within 2 weeks of baseline endoscopy
Severe renal failure
Hepatic failure (Prothrombin time (PT) >15 s or INR >1.5 with evidence of encephalopathy or PT >20 s or INR >2 without encephalopathy)
Existence of haemorrhagic diathesis, use of anti-coagulant drugs
Need for topical or systemic steroids for other conditions during the study period
Current pregnancy or breastfeeding
Psychiatric conditions that reduce compliance with the protocol
Primary or secondary immune deficiency
Ongoing chronic or acute infectious diseases (viral, bacterial, parasitic)
Previous hypersensitivity reactions to budesonide or excipients
Allergy to nickel, soya, gluten
Diabetes or other chronic organic diseases
Oral or oesophageal candidiasis
Oesophageal stenosis
Use of steroids (topical or systemic) within 4 weeks of baseline endoscopy, including combined hormonal contraceptives (except low-dose)
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction/disappearance of eosinophil count in oesophageal mucosa (<15 EoE/HPF) after viscous budesonide therapy (T12) Reduction/disappearance of eosinophil count in oesophageal mucosa (<15 EoE/HPF) after viscous budesonide therapy (T12)
- Secondary Outcome Measures
Name Time Method Reduction of the symptomatic score calculated after therapy (T12) Reduction of the symptomatic score calculated after therapy (T12)
Reduction in endoscopic 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) Monitoring and collection of adverse events (AEs) and severe adverse events (SAEs) (T6; T12)
Trial Locations
- Locations (1)
University Of Bari Aldo Moro
🇮🇹Bari, Italy
University Of Bari Aldo Moro🇮🇹Bari, ItalyRuggiero FrancavillaSite contact+390805596798pediatriageneraletrambusti.segreteria@policlinico.ba.it