Immune System Disorders
Conditions
Keywords
vaccine response, immune system activity
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALmicrobial inoculate
volunteers will regularly receive microbial inoculate that they do not use orally
Sponsors
Tampere University
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in blood serum's cytokine levels | 1-3 months | it will be checked if the values are different in different arms |
| difference in blood serum IgE levels | 1-3months | in will be chekced if the values are different in different arms |
| Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention) | 1-3 months | it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community | 1-3 months | it will be analyzed if microbial communities are similar in both arms |
| difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community | 1-3 months | it will be analyzed if microbial communities are similar in both arms |
| Number of participants with treatment-related adverse events as assessed by a questionnaire described below | 1-3 months | 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. |
Countries
Finland
Outcome results
None listed