2024-519269-23-00招募中3 期
Evaluation of the efficacy of topical treatment with budesonide in children with Crohn's disease located in the esophagus and/or stomach and/or duodenum - BETHESDa
Medical University Of Warsaw3 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年12月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum
研究概览
简要总结
THE OBJECTIVE OF THE STUDY IS TO ASSESS THE EFFECTIVENESS OF TOPICALLY APPLIED BUDESONIDE IN THE TREATMENT OF INFLAMMATIVE LEASES IN THE OESPHAGOM AND/OR THE GASTRIC AND/OR THE DUDENUM IN CHILDREN WITH LEŚNIOWSKI-CROHN'S DISEASE
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •CD diagnosed according to commonly accepted criteria from Porto, 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 (on the Paris scale CD-C activity: L4a, i.e. involvement of the upper gastrointestinal tract to the Treitz ligament)
- •stable, understood as no treatment modification, CD treatment for ≥2 weeks; exclusion of causes of inflammatory changes in the esophagus and/or stomach and/or duodenum other than CD, such as: reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, Helicobacter pylori infection
- •informed consent of the child's parents or guardians to participate in the study; for children ≥ 16 years of age additionally, the consent of the child participating in the study declaration of sexual abstinence during the entire participation in the study
- •declaration of sexual abstinence during the entire participation in the study
排除标准
- •age <6 years or >18 years of age
- •breastfeeding;
- •lack of consent of a woman of reproductive age or a fertile man to follow contraceptive recommendations during the examination;
- •the patient has had cancer
- •other causes of inflammatory changes in the esophagus and/or stomach and/or duodenum, other than CD, such as reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, infection Helicobacter pylori;
- •use of general steroids up to 30 days prior to study entry
- •use of inhaled steroids up to 30 days prior to study entry;
- •PPI use up to 30 days prior to study entry;
- •acute viral or bacterial infection up to 30 days prior to study entry;
- •morning cortisol <5 ug/dL;
- •lack of informed consent of the child's parents or guardians to participate in the study; for children ≥16 years of age lack of consent of the child to participate in the study.
- •patient's pregnancy;
结局指标
主要结局
Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum
Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum
次要结局
- disease activity assessed on the PCDAI scale (Pediatric Crohn Disease Activity Index) assessed in the 8th week;
- the percentage of patients whose upper gastrointestinal symptoms disappeared - 4th, 8th, 12th week;
- a percentage of patients with adverse effects of steroids - 4th, 8th, 12th week;
- assessment of treatment tolerance on a 10-point VAS scale - 4th, 8th week.
- the proportion of patients with no evidence of endoscopic changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the tests) - 8th week;
- percentage of patients with no histopathological changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the study) - 8th week;
研究者
Aleksandra Banaszkiewicz
Scientific
Medical University Of Warsaw
研究点 (3)
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