Effect of acid suppressive therapy on the bacteria in the small bowel in functional dyspepsia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

- 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

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