The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
November 30, 2016 updated by: Lund University
In the present study the main goal has been to clarify the effect of the probiotic bacteria Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress.
Salivary IgA from minor glands and in whole human saliva was measured as alternative marker of stress.
The hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress.
By contrast, the salivary IgA levels were expected to increase in the test group in comparison to the placebo group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults
- studying at the University in Lund
- participation in ongoing examination period
Exclusion Criteria:
- pregnancy
- intake of antibiotics
- medication with cortisone during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Probiotic
Capsules containing potato starch as a filler and Lactobacillus plantarum
|
|
|
Placebo Comparator: Placebo
Capsules containing potato starch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.
Time Frame: Change from baseline in cortisol levels at 14 days
|
Change from baseline in cortisol levels at 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exjobb stress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.