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Effect of Microbial Exposure on Health, Particularly Immune System

NCT ID: NCT03351543

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

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.

Conditions

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Immune System Disorders

Keywords

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vaccine response immune system activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exposed group

these volunteers receive microbial inoculate

Group Type EXPERIMENTAL

microbial inoculate

Intervention Type BIOLOGICAL

volunteers will regularly receive microbial inoculate that they do not use orally

control

these volunteers do not receive microbial inoculate

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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microbial inoculate

volunteers will regularly receive microbial inoculate that they do not use orally

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Aki Sinkkonen

University researcher, docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aki Sinkkonen, Ph D Docent

Role: STUDY_CHAIR

University of Helsinki

Locations

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Helsinki University

Lahti, Kanta-Häme, Finland

Site Status

Countries

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Finland

Other Identifiers

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HelsinkiUADELEWP1t4

Identifier Type: -

Identifier Source: org_study_id