Functional Dyspepsia (FD)
Conditions
Sponsors
TARGID, KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with FD diagnosis as per Rome IV criteria - Endoscopy needed as part of routine practice - Subjects aged between 18 and 64 years inclusive - Male or female (not pregnant or lactating and using contraception or postmenopausal in FD cohort 1 only) - Normal bowel habits (defecation once every 3 days up to 3 times a day) - Witnessed written informed consent - Access to home freezer (-18 to -20°C) - Capable to understand and 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any active somatic or psychiatric condition that can explain the dyspeptic symptoms (stable dose of single antidepressant allowed) - Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS) - Use of immunosuppressants or antibiotics within 3 months before sampling - Use of drugs influencing gut motility or stool consistency, NSAIDs, anti-allergy drugs, bile acid sequestrants or ursodeoxycholic acid within 2 weeks before sampling - History of major abdominal surgery, including cholecystectomy but not appendectomy -Personal or family (first-degree relative) history of diabetes mellitus type 1, celiac disease, inflammatory bowel disease, psoriasis, rheumatic or other auto-immune diseases (including therapy) -Allergy or atopy (eczema, asthma and/or allergic rhinoconjunctivitis) (including therapy) -Kidney, liver or coagulation disorders -Active coronary or peripheral artery disease -Diabetes mellitus type 2 (including therapy) - Active malignancy (including therapy) -Known HIV, HBV or HCV infection (including therapy) - Magnetizable objects (e.g. cochlear implants, neural stimulator, pacemaker, metal fragments or implants) or claustrophobia (MRI safety criteria, other procedures can still take place) - Significant alcohol use (>10 units/weeks) - Any use of alcohol or smoking in the 2 days before sampling - Females who are pregnant or lactating, who are not using contraception and premenopausal (FD cohort 1 only) - Allergy or intolerance to PPI (FD cohort 1 only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in FD patients before and after start PPI during 4 weeks (FD cohort 1) ;Secondary Objective: Correlate changes in the microbiota with clinical response, bile acids, intestinal permeability, mucosal inflammation, salivary cortisol levels and blood high sensitivity-CRP.;Primary end point(s): Microbiota composition of the duodenum, feces and saliva;Timepoint(s) of evaluation of this end point: Study inclusion, after baseline period of 4 weeks and after treatment with Pantomed 40mg once daily for 4 weeks (FD cohort 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical response, bile acids, intestinal permeability, mucosal inflammation, salivary cortisol and blood hs-CRP;Timepoint(s) of evaluation of this end point: Study inclusion, after baseline period of 4 weeks and after treatment with Pantomed 40mg once daily for 4 weeks (FD cohort 1) | — |
Countries
Belgium
Contacts
Public ContactTARGID
TARGID, KU Leuven
Outcome results
None listed