The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.
The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
volunteers will regularly receive microbial inoculate that they do not use orally
Helsinki University
Lahti, Kanta-Häme, Finland
difference in blood serum's cytokine levels
it will be checked if the values are different in different arms
Time frame: 1-3 months
difference in blood serum IgE levels
in will be chekced if the values are different in different arms
Time frame: 1-3months
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections
Time frame: 1-3 months
difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community
it will be analyzed if microbial communities are similar in both arms
Time frame: 1-3 months
difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community
it will be analyzed if microbial communities are similar in both arms
Time frame: 1-3 months
Number of participants with treatment-related adverse events as assessed by a questionnaire described below
In the end of the experimental period and 2-4 weeks later, all study participants fill a questionnaire. It will be asked if the volunteers experienced a negative change in mental well-being during the study period. Similarly, they will be specifically asked for itches, skin symptoms and signs of infections. And index (how may yes-answers) will be compared between treatment and control groups.
Time frame: 1-3 months
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