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

Medical University of Warsaw0 sites138 target enrollmentJanuary 15, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 15, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Medical University of Warsaw

•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

•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.