sepsis, gut flora depletion, systemic immune response
Conditions
Interventions
All volunteers will self-administer the following antibiotics for 7 consecutive days (concomitantly):
1. Vancomycin 250mg 3dd2
2. Ciprofloxacin 500mg 2dd1
3. Metronidazol 500mg 3dd1.
Sponsors
Academisch Medisch Centrum, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy; 2. Male between 18 and 35 years of age; 3. Capable of giving written informed consent and able to comply with the requirements and restrictions; 4. Chemistry panel without any clinically relevant abnormality; 5. Normal defecation pattern (defined as 3x/week).
Exclusion criteria
Exclusion criteria: 1. Major illness in the past 3 months or significant chronic medical illness; 2. History of any type of malignancy; 3. Past or current gastrointestinal disease which may influence the gut microbiota; 4. Known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV; 5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities; 6. Use of tobacco products; 7. History, within 3 years, of drug abuse; 8. History of alcoholism and/or drinking more than 3 units of alcohol per day; 9. The subject has received an investigational product within three months of day 1; 10. Use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months; 11. Recent (< 12 months) use of antibiotics (any kind, except for dermal antibiotics); 12. Allergy to antibiotics (any kind); 13. Difficulty swallowing pills; 14. Any other relevant issue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects, laboratory measurements, functional assays and microbiota composition. 1. Side effects will be registered using a graded scale; 2. A HITchip (16S rRNA) analysis to determine microbiome composition; 3. Laboratory measurements: include inflammatory markers, neutrophil activation and -degranulation; 4. Functional assays: ex vivo stimulation of blood cells with nosocomial pathogens. | — |
Contacts
Public ContactJ.M. Lankelma
CEMM, Department of Internal Medicine Academic Medical Center University of Amsterdam Meibergdreef 9
Outcome results
None listed