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

Primary Purpose

Immune System Disorders

Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
microbial inoculate
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Immune System Disorders focused on measuring vaccine response, immune system activity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Helsinki University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposed group

control

Arm Description

these volunteers receive microbial inoculate

these volunteers do not receive microbial inoculate

Outcomes

Primary Outcome Measures

difference in blood serum's cytokine levels
it will be checked if the values are different in different arms
difference in blood serum IgE levels
in will be chekced if the values are different in different arms
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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
March 23, 2016
Last Updated
November 19, 2017
Sponsor
University of Helsinki
Collaborators
Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT03351543
Brief Title
Effect of Microbial Exposure on Health, Particularly Immune System
Acronym
ADELEWP1t4
Official Title
ADELE: Autoimmune Defense and Living Environment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Tampere University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Disorders
Keywords
vaccine response, immune system activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposed group
Arm Type
Experimental
Arm Description
these volunteers receive microbial inoculate
Arm Title
control
Arm Type
No Intervention
Arm Description
these volunteers do not receive microbial inoculate
Intervention Type
Biological
Intervention Name(s)
microbial inoculate
Intervention Description
volunteers will regularly receive microbial inoculate that they do not use orally
Primary Outcome Measure Information:
Title
difference in blood serum's cytokine levels
Description
it will be checked if the values are different in different arms
Time Frame
1-3 months
Title
difference in blood serum IgE levels
Description
in will be chekced if the values are different in different arms
Time Frame
1-3months
Title
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
Description
it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community
Description
it will be analyzed if microbial communities are similar in both arms
Time Frame
1-3 months
Title
difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community
Description
it will be analyzed if microbial communities are similar in both arms
Time Frame
1-3 months
Title
Number of participants with treatment-related adverse events as assessed by a questionnaire described below
Description
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.
Time Frame
1-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aki Sinkkonen, Ph D Docent
Organizational Affiliation
University of Helsinki
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University
City
Lahti
State/Province
Häme
ZIP/Postal Code
15140
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Effect of Microbial Exposure on Health, Particularly Immune System

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