Effect of Microbial Exposure on Health, Particularly Immune System

NCT03351543 | Completed Phase 1

• 1 other identifier: HelsinkiUADELEWP1t4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System Disorders

Keywords

vaccine response; immune system activity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  1-3 months

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

  1-3 months

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

  1-3 months

Study Arms (2)

Exposed group

EXPERIMENTAL

these volunteers receive microbial inoculate

Biological: microbial inoculate

control

NO INTERVENTION

these volunteers do not receive microbial inoculate

Interventions

microbial inoculate BIOLOGICAL

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

Exposed group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead
• Tampere University: collaborator

Study Sites (1)

Helsinki University

Lahti, Kanta-Häme, 15140, Finland

Location

MeSH Terms

Conditions

Immune System Diseases

Study Officials

• Aki Sinkkonen, Ph D Docent

  University of Helsinki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University researcher, docent

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: November 24, 2017
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)