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Completed

NCT Number: NCT03351543

Effect of Microbial Exposure on Health, Particularly Immune System

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.

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Key information

Conditions

Immune System Disorders Immune System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Helsinki University

Lahti, Kanta-Häme, 15140, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

microbial inoculate

Biological

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

Primary outcomes

  1. difference in blood serum's cytokine levels

    Time frame: 1-3 months

    it will be checked if the values are different in different arms

  2. difference in blood serum IgE levels

    Time frame: 1-3months

    in will be chekced if the values are different in different arms

  3. Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)

    Time frame: 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 outcomes

  1. difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community

    Time frame: 1-3 months

    it will be analyzed if microbial communities are similar in both arms

  2. difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community

    Time frame: 1-3 months

    it will be analyzed if microbial communities are similar in both arms

  3. Number of participants with treatment-related adverse events as assessed by a questionnaire described below

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Tampere University

Registry information

Official study title

ADELE: Autoimmune Defense and Living Environment

Acronym: ADELEWP1t4

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 24, 2017
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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