The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress

Stress Reaction Clinical Trial

Official title:

The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974894
• Other study ID #: Exjobb stress
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: November 30, 2016
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Stress
• Stress Reaction

Intervention

Dietary Supplement:
• Probiotic (Lactobacillus Plantarum)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.		Change from baseline in cortisol levels at 14 days	No