drugset / Trial / NCT02340182

The Role of the Microbiota in the Systemic Immune Response

NCT02340182

NaSingle-groupOpen-labelBasic science

Summary

The objective of this study is to investigate the role of the gut microbiota in the systemic priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24 hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation assay) and gut microbiota composition.

Timeline

Start
2013-03
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciprofloxacin Small molecule 500 mg
Subject Metronidazole Small molecule 500 mg
Subject Vancomycin Other / unclassified 250 mg