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

NCT ID: NCT02974894

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Capsules containing potato starch as a filler and Lactobacillus plantarum

Group Type EXPERIMENTAL

Probiotic (Lactobacillus Plantarum)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsules containing potato starch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotic (Lactobacillus Plantarum)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 28101105 (View on PubMed)

Other Identifiers

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Exjobb stress

Identifier Type: -

Identifier Source: org_study_id