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Effect of Microbial Exposure on Health, Particularly Immune System (ADELEWP1t4)

U

University of Helsinki

Status and phase

Completed
Phase 1

Conditions

Immune System Disorders

Treatments

Biological: microbial inoculate

Study type

Interventional

Funder types

Other

Identifiers

NCT03351543
HelsinkiUADELEWP1t4

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Exposed group
Experimental group
Description:
these volunteers receive microbial inoculate
Treatment:
Biological: microbial inoculate
control
No Intervention group
Description:
these volunteers do not receive microbial inoculate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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