Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
The overall aim of the project is to fill an important knowledge gap on the ecological
effects of selected antibiotics. The results will be used to guide treatment decisions for
common infections to as much as possible reduce the negative impact on the intestinal
microbiota and consequently the risks of side effect and resistance development during
therapy.
Specific aims for this study are to determine (1) the composition of intestinal microbiota
and prevalence of resistant bacteria and resistance genes prior to and up to 1 year after
antibiotic treatment, and (2) the relative effects on the microbiota after treatment with
three antibiotics used for lower respiratory tract infections; phenoximethylpenicillin,
amoxicillin and amoxicillin-clavulanic acid, or no treatment (control).
A total of 120 healthy volunteers will be recruited to the study. They are randomised to 5
days' treatment with phenoximethylpenicillin, amoxicillin or amoxicillin-clavulanic acid, or
to no antibiotic treatment. Subjects submit faecal samples at eight different time-points; at
the start of the study (before treatment), immediately, one week and 1, 3, 6, 12 and 24
months after completion of the treatment. The samples will be delivered to Scilifelab for
metagenomic sequencing to detect antibiotic resistant genes and analysis of the intestinal
microbiota and to the Microbiology ward for analysis with phenotypic methods (culturomics) to
detect resistant genes and resistant bacteria.
Phase:
Phase 4
Details
Lead Sponsor:
Uppsala University
Treatments:
Amoxicillin Amoxicillin-Potassium Clavulanate Combination Clavulanic Acid Clavulanic Acids Penicillin V