Effect of Microbial Exposure on Health, Particularly Immune System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ADELE: Autoimmune Defense and Living Environment

Conditions
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Immune System Disorders

Intervention / Treatment
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* Biological: microbial inoculate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposed group<br>these volunteers receive microbial inoculate | Biological: microbial inoculate<br>* volunteers will regularly receive microbial inoculate that they do not use orally<br>|
| No Intervention: control<br>these volunteers do not receive microbial inoculate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine response, immune system activity