<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02974894</url>
  </required_header>
  <id_info>
    <org_study_id>Exjobb stress</org_study_id>
    <nct_id>NCT02974894</nct_id>
  </id_info>
  <brief_title>The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress</brief_title>
  <official_title>The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study the main goal has been to clarify the effect of the probiotic bacteria&#xD;
      Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination&#xD;
      stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative&#xD;
      marker of stress. The hypothesis was that the levels of cortisol would be reduced or&#xD;
      stabilized in the test group in comparison to the placebo group where the cortisol levels&#xD;
      were expected to increase due to the examination-induced stress. By contrast, the salivary&#xD;
      IgA levels were expected to increase in the test group in comparison to the placebo group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.</measure>
    <time_frame>Change from baseline in cortisol levels at 14 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Stress Reaction</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing potato starch as a filler and Lactobacillus plantarum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules containing potato starch</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic (Lactobacillus Plantarum)</intervention_name>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  studying at the University in Lund&#xD;
&#xD;
          -  participation in ongoing examination period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  intake of antibiotics&#xD;
&#xD;
          -  medication with cortisone during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02974894
org study id: Exjobb stress
nct id: NCT02974894
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
arm group label: Probiotic
arm group type: Experimental
description: Capsules containing potato starch as a filler and Lactobacillus plantarum
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsules containing potato starch
intervention type: Dietary Supplement
intervention name: Probiotic (Lactobacillus Plantarum)
arm group label: Probiotic
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Fractures, Stress
sharing ipd: No