Evaluation of the efficacy of topical budesonide in the treatment of esophagogastroduodenal Crohn's disease in childre

Phase 1

• Conditions: Crohn's disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004168-24-PL
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-15
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

age 6-18 years;

Crohn's disease diagnosed according to commonly accepted Porto criteria, taking into account clinical, endoscopic and histopathological criteria;

inflammatory changes in the esophagus and / or stomach and / or duodenum found in an endoscopic examination (assessed by 2 independent endoscopists) and confirmed in a histopathological examination (in the Paris scale, activity of Crohn's disease: L4a, i.e. the involvement of the upper gastrointestinal tract into the Treitz ligament);

stable, understood as no treatment modification, Crohn's disease treatment for =2 weeks;

exclusion of other causes of inflammatory changes in the esophagus and / or stomach and / or duodenum, other than Crohn's disease, such as: reflux oesophagitis, herpetic esophagitis, cytomegaloviral oesophagitis, eosinophilic oesophagitis and / or gastroduodenitis, Helicobacter pylori infection;

informed consent of the child's parents or guardians to participate in the study; in the case of children = 16 years of age additionally, the consent of the child participating in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 138
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

age <6 years old or> 18 years of age;

causes of inflammatory changes in the esophagus and / or stomach and / or duodenum, other than Crohn's disease, such as: reflux oesophagitis, herpetic oesophagitis, cytomegaloviral oesophagitis, eosinophilic oesophagitis and / or gastroduodenitis, Helicobacter pylori;

use of steroids in general up to 30 days prior to study enrollment;

use of inhaled steroids up to 30 days prior to study enrollment;

use of PPIs up to 30 days prior to study inclusion;

acute viral or bacterial infection up to 30 days prior to study enrollment;

morning cortisol <5 µg / dL;

lack of informed consent of the parents or guardians of the child to participate in the study; in the case of children =16 years of age the child's refusal to take part in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified