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

ADELE: Autoimmune Defense and Living Environment

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.

Study Overview

• Status: Completed
• Conditions: Immune System Disorders
• Intervention / Treatment: Biological: microbial inoculate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Häme
    • Lahti, Häme, Finland, 15140
      • Helsinki University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposed group; these volunteers receive microbial inoculate	Biological: microbial inoculate; volunteers will regularly receive microbial inoculate that they do not use orally
No Intervention: control; these volunteers do not receive microbial inoculate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Tampere University
• Investigators: Study Chair: Aki Sinkkonen, Ph D Docent, University of Helsinki

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: November 19, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 19, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: vaccine response; immune system activity
• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: HelsinkiUADELEWP1t4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be publicly available according to the instructions of Tekes, the funder. We can publish the data when we know the results and we have to publish it when the project ends.