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| Name | Class |
|---|---|
| Tampere University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | Experimental | these volunteers receive microbial inoculate |
|
| control | No Intervention | these volunteers do not receive microbial inoculate |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microbial inoculate | Biological | volunteers will regularly receive microbial inoculate that they do not use orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in blood serum's cytokine levels | it will be checked if the values are different in different arms | 1-3 months |
| difference in blood serum IgE levels | in will be chekced if the values are different in different arms | 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 | 1-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1-3 months |
| difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aki Sinkkonen, Ph D Docent | University of Helsinki | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University | Lahti | Kanta-Häme | 15140 | Finland |
The data will be publicly available according to the instructions of Tekes, the funder. We can publish the data when we know the results and we have to publish it when the project ends.
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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it will be analyzed if microbial communities are similar in both arms |
| 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. | 1-3 months |