The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
1 other identifier
interventional
42
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedDecember 1, 2016
November 1, 2016
28 days
November 21, 2016
November 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.
Change from baseline in cortisol levels at 14 days
Study Arms (2)
Probiotic
EXPERIMENTALCapsules containing potato starch as a filler and Lactobacillus plantarum
Placebo
PLACEBO COMPARATORCapsules containing potato starch
Interventions
Eligibility Criteria
You may qualify if:
- adults
- studying at the University in Lund
- participation in ongoing examination period
You may not qualify if:
- pregnancy
- intake of antibiotics
- medication with cortisone during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Related Publications (1)
Andersson H, Tullberg C, Ahrne S, Hamberg K, Lazou Ahren I, Molin G, Sonesson M, Hakansson A. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial. Int J Microbiol. 2016;2016:8469018. doi: 10.1155/2016/8469018. Epub 2016 Dec 22.
PMID: 28101105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2016
First Posted
November 29, 2016
Study Start
February 1, 2013
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
December 1, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share