Oral viscous budesonide administration for 3 months in a population of patients affected by esophageal atresia and eosinophilic esophagitis.
- Conditions
- Eosinophilicesophagitis (EoE) in Esophageal atresia (EA).Therapeutic area: Diseases [C] - Digestive System Diseases [C06]MedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2019-002691-14-IT
- Lead Sponsor
- IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9
-Informed consent form of subjects fully capable of providing consent or parent/s, legal representative of minors according to the national law; assent in pre-pubertal (6-11 years) and (12-17 years).
- Male/female subjects aged 31 month- =18 years
-Patients operated for EA (direct anastomosis) with eosinophilic esophagitis, diagnosed histologically after endoscopy no more than 3 months before joining the trial and defined according to the most recent guidelines on EoE and according to Paediatric Gastrointestinal Endoscopy guidelines: 15 or more eosinophils per high- power field (0.3 mm2), as peak concentration in esophageal biopsy samples (at least 3 sites, with at least 1-2 biopsies from the proximal, medium and distal esophagus).
-Potentially fertile patients (post-menarcal girls) must have a negative pregnancy test at screening before inclusion in the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Patients operated for esophageal atresia with jejunal or colonic interposition
-Presence of concomitant esophago-gastrointestinal disorders
- Weight less than 10 kg
-Eosinophilia in other gastrointestinal tracts
-Participation in other clinical trials
- Allergic asthma and rhinitis during the month before the biopsy required for the study
- Allergic reactions
- Anticoagulant and immunomodulatory concomitant use
- Topical/systemic steroids during the month before the biopsy required for the study
- Hypersensitivity to the active substance, to any of the excipients
- Inability or difficulty swallowing the drug
- Chronic viral infections or immunodeficiency
- Ongoing oropharyngeal candidiasis
- Neurological development delay
known cardiac, hepatic and renal disorders: condition of severe renal insufficiency at screening in terms of estimated GFR <30Ml / min / 1.73m ^ 2; liver failure in terms of ALT or AST> 3 × ULN and total Bilirubin> 1.7x ULN; heart failure (NYHA or Ross stage equal to or greater than 2)
- Any laboratory abnormality which, in the opinion of the investigator, would make the patient unsuitable for the study.
- If applicable, potentially fertile patients unable or unwilling to undergo pregnancy tests and to practice contraceptive measures from the time of informed consent up to 30 days after the last administration of the IMP
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method