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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Subjects aged between 18 and 64 years inclusive
- Male or female (not pregnant or lactating and using contraception or postmenopausal)
- 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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Active gastrointestinal or psychiatric symptoms (stable dose of single antidepressant allowed)
- Use of acid suppressive drugs, 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
- Allergy or intolerance to PPI

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 healthy volunteers;Secondary Objective: Correlate changes in the microbiota with bile acids, intestinal permeability and histology, salivary cortisol levels and blood hs-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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 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

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