Functional dyspepsia
Conditions
Interventions
Trade Name: Jorveza
Product Name: Budesonide
Pharmaceutical Form: Capsule
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The effect of Budesonide on duodenal eosinophilia in functional dyspepsia patients.;Secondary Objective: The effect of budesonide in functional dyspepsia on -gastric emptying -symptom outcome -quality of life in patients -state of anxiety, depression and somatization -mucosal barrier function ;Primary end point(s): Duodenal eosinophils;Timepoint(s) of evaluation of this end point: Before treatment and after 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS) - Quality of life of patients - State of anxiety, depression and somatization - Mucosal permeability, including gene and protein expression of major tight-junction related molecules and cytokines - Gastric motility by assessing gastric emptying time ;Timepoint(s) of evaluation of this end point: Before treatment and after 8 weeks of treatment. Gastrointestinal symptoms will be evaluated daily via the LPDS diary. | — |
Countries
Belgium
Contacts
Public ContactTARGID
KU Leuven
Outcome results
None listed