Budesonide as a treatment for low-grade duodenal inflammation in functional dyspepsia. - BUDY

Z Leuven0 个研究点目标入组 36 人开始时间: 2022年4月12日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable to participate in 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
•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.

发起方

Z Leuven