Budesonide as a treatment for inflammation in stomach complaints.
- Conditions
- Functional dyspepsiaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-002593-27-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 36
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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