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

Primary Purpose

Stress Reaction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic (Lactobacillus Plantarum)
Placebo
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Reaction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic

    Placebo

    Arm Description

    Capsules containing potato starch as a filler and Lactobacillus plantarum

    Capsules containing potato starch

    Outcomes

    Primary Outcome Measures

    The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2016
    Last Updated
    November 30, 2016
    Sponsor
    Lund University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02974894
    Brief Title
    The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
    Official Title
    The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lund University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Reaction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Experimental
    Arm Description
    Capsules containing potato starch as a filler and Lactobacillus plantarum
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Capsules containing potato starch
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic (Lactobacillus Plantarum)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28101105
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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