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

Medical University of Warsaw0 个研究点目标入组 138 人开始时间: 2021年1月15日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Medical University of Warsaw