Effect of Microbial Exposure on Health, Particularly Immune System

Immune System Disorders Clinical Trial

— ADELEWP1t4  

Official title:

ADELE: Autoimmune Defense and Living Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351543
• Other study ID #: HelsinkiUADELEWP1t4
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2016
• Last updated: November 19, 2017
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System Diseases
• Immune System Disorders

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University	Lahti	Häme

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in blood serum's cytokine levels	it will be checked if the values are different in different arms	1-3 months
Primary	difference in blood serum IgE levels	in will be chekced if the values are different in different arms	1-3months
Primary	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	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
Secondary	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
Secondary	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