<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/NCT03284905</url>
  </required_header>
  <id_info>
    <org_study_id>SP17</org_study_id>
    <nct_id>NCT03284905</nct_id>
  </id_info>
  <brief_title>Probiotic Intervention for Acute Stress</brief_title>
  <official_title>Probiotic Intervention for Acute Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Probi AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Probi AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy of probiotics on acute stress&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">April 4, 2018</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>Reduction of the cortisol level during acute stress</measure>
    <time_frame>2.5 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Probiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic supplement</intervention_name>
    <description>Capsule containing freeze dried probiotic bacteria together with maize starch</description>
    <arm_group_label>Probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo supplement</intervention_name>
    <description>Capsule containing maize starch</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19-35 years&#xD;
&#xD;
          -  SMBQ-score ≥3.75&#xD;
&#xD;
          -  Understand Swedish in spoken and written terms&#xD;
&#xD;
          -  Willing and able to give written informed consent for participating in the study&#xD;
&#xD;
          -  Intake of probiotics within two weeks prior to the start of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI&gt; 30&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Antibiotic treatment in the last three months&#xD;
&#xD;
          -  Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid&#xD;
             problems, gastrointestinal disease) or mental illness&#xD;
&#xD;
          -  Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs,&#xD;
             steroid drugs or local steroid treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Food Technology, Engineering and Nutrition, Lund University</name>
      <address>
        <city>Lund</city>
        <zip>223 00</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03284905
org study id: SP17
nct id: NCT03284905
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Efficacy of probiotics on acute stress
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction of the cortisol level during acute stress
time frame: 2.5 hours
arm group label: Probiotics
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Probiotic supplement
description: Capsule containing freeze dried probiotic bacteria together with maize starch
arm group label: Probiotics
intervention type: Dietary Supplement
intervention name: Placebo supplement
description: Capsule containing maize starch
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No