PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

• Status: Completed
• Trial end date: 2020-09-22
• Target enrollment: 0
• Participant gender: All

Summary

Prospective interventional study of the effect of PPI on the duodenal microbiome in healthy volunteers and functional dyspepsia patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Pantoprazole; Proton Pump Inhibitors

Criteria

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

Exclusion Criteria:

• Active psychiatric symptoms (stable dose of single antidepressant allowed)

• Use of acid suppressive drugs (before starting Pantomed), immunosuppressants or antibiotics <3 months before sampling

• Use of drugs influencing stool consistency, NSAIDs, anti-allergy drugs, bile acid sequestrants or ursodeoxycholic acid <2 weeks before sampling

• Use of prokinetics <2 weeks before sampling (unless if ≤3/week)

• History of major abdominal surgery, including cholecystectomy but not appendectomy or splenectomy

• 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 with additional consent form, other procedures can still take place)

• Significant alcohol use (>10 units/weeks)

• Any use of alcohol or smoking ≤2 days before sampling

• Females who are pregnant or lactating, who are not using contraception and premenopausal