2024-517035-43-00招募中4 期
Budesonide as a treatment for low-grade duodenal inflammation in functional dyspepsia.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Duodenal eosinophils before treatment and after 8 weeks of treatment
研究概览
简要总结
The effect of Budesonide on duodenal eosinophilia in functional dyspepsia patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Functional dyspepsia patients with meal related symptoms (postprandial distress syndrome) as described by the Rome IV criteria
- •Patients aged between 18 and 70 years inclusive
- •Male or female patients
排除标准
- •Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable to participate in the study
- •Patients who take drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism
- •Patients with major change in diet in the last 3 months
- •Females who are pregnant or lactating
- •Patients not capable to understand or be compliant with the study.
- •Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
- •Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD)
- •Patients with diabetes mellitus, celiac disease, lupus, scleroderma or other systemic auto-immune disease
- •Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
- •Patients with active H. Pylori infection (or < 6 months after eradication)
- •Patients with proven food allergy
- •Patients with an organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy
- •Patients with known sever impaired liver dysfunction
结局指标
主要结局
Duodenal eosinophils before treatment and after 8 weeks of treatment
Duodenal eosinophils before treatment and after 8 weeks of treatment
次要结局
- Gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS) before treatment and after 8 weeks of treatment
- Quality of life of patients before treatment and after 8 weeks of treatment
- State of anxiety, depression and somatization before treatment and after 8 weeks of treatment
- Mucosal permeability, including gene and protein expression of major tight-junction related molecules and cytokines before treatment and after 8 weeks of treatment
- Gastric motility by assessing gastric emptying time, gastric sensitivity to distension and gastric accommodation reflex before treatment and after 8 weeks of treatment
- The mucosa-associated microbiome before treatment and after 8 weeks of treatment
研究者
Tim Vanuytsel
Scientific
UZ Leuven
研究点 (1)
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