Effect of Microbial Exposure on Health, Particularly Immune System

Phase 1

Completed

• Conditions: Immune System Disorders
• Interventions: Biological: microbial inoculate

• Registration Number: NCT03351543
• Lead Sponsor: University of Helsinki

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-23
• Primary Completion: 2016-06
• Study Completion: 2017-07
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-19
• Last Update Submitted: 2017-11-19
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposed group	microbial inoculate	these volunteers receive microbial inoculate

Primary Outcome Measures

Name	Time	Method
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)	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
difference in blood serum's cytokine levels	1-3 months	it will be checked if the values are different in different arms
difference in blood serum IgE levels	1-3months	in will be chekced if the values are different in different arms

Secondary Outcome Measures

Name	Time	Method
difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community	1-3 months	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	1-3 months	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	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.

Trial Locations

Locations (1)

Helsinki University; 🇫🇮 Lahti, Häme, Finland