Functional Dyspepsia (FD)
Conditions
Interventions
Trade Name: Pantomed
Product Name: Pantomed 40mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PANTOPRAZOLE
CAS Number: 102625-70-7
Other descriptive name: PANTOPRAZOLE
Concentration unit: mg milli
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with FD diagnosis as per Rome IV criteria (EPS or PDS). • Normal investigation including upper GI endoscopy. • Patients have confirmed duodenal mucosal eosinophilia. • Patients witnessed written informed consent. • Patients aged between 18 and 64 years inclusive. • Male or female (not pregnant or lactating and using contraception or postmenopausal). • Subjects are capable to understand the study and the questionnaires, and to comply with the study requirements. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study. • Patients with any major psychiatric disorders (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications). • Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD). • Patients with personal or family (first-degree relative) of diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, lupus, scleroderma, rheumatic or other systemic auto-immune disease. • Patients with eosinophilic esophagitis or eosinophilic gastroenteritis. • Active H. pylori infection (or 10 units/week). • Any use of alcohol or smoking <2 days before sampling. • Active malignancy, including therapy. • 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: To assess the effect of proton pump inhibitors (PPI) on duodenal submucosal nerve responses in FD;Secondary Objective: To assess the effects of PPI in FD on duodenal mucosal and systemic inflammation, quality of life, symptoms, salivary cortisol levels, stool microbiota and urine metabolites;Primary end point(s): The effect of PPI on duodenal submucosal nerve responses in FD;Timepoint(s) of evaluation of this end point: Baseline study visit and visit after run-in period and treatment period with Pantomed 40mg twice daily for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duodenal mucosal and systemic inflammation, quality of life, symptoms, salivary cortisol levels, stool microbiota and urine metabolites;Timepoint(s) of evaluation of this end point: Baseline study visit and visit after run-in period and treatment period with Pantomed 40mg twice daily for 4 weeks | — |
Countries
Belgium
Contacts
Public ContactLucas Wauters
University Hospitals Leuven
Outcome results
None listed