<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/NCT03234452</url>
  </required_header>
  <id_info>
    <org_study_id>Lactoflorene plus</org_study_id>
    <nct_id>NCT03234452</nct_id>
  </id_info>
  <brief_title>Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.</brief_title>
  <official_title>Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefarmaco OTC SpA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefarmaco OTC SpA</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>
      A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in&#xD;
      Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of&#xD;
      inflammation and intestinal barrier function and gastrointestinal symptoms in healthy&#xD;
      volunteers with self-reported anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2016</start_date>
  <completion_date type="Actual">April 18, 2017</completion_date>
  <primary_completion_date type="Actual">July 21, 2016</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>Crossover Assignment</intervention_model>
    <intervention_model_description>randomized, double-blind, placebo-controlled, cross-over trial performed at one centre</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>NK activity</measure>
    <time_frame>45 days</time_frame>
    <description>Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IgA, IL8, TNF-Alpha, IL10</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol, alpha-amylase , chromogranin A</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiota composition investigation</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Disbiosis</condition>
  <condition>Abdominal Pain</condition>
  <condition>Constipation</condition>
  <condition>Diarrhea</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Lactoflorene plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Lactoflorene plus</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactoflorene plus</intervention_name>
    <description>2 vials with dosing cap (10 mL) a day per os</description>
    <arm_group_label>Lactoflorene plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo Lactoflorene plus</intervention_name>
    <description>2 vials with dosing cap (10 mL) a day per os</description>
    <arm_group_label>Placebo Lactoflorene plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y,&#xD;
        module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics&#xD;
        within 30 days prior to the screening visit, and use of drugs, food or herbal supplements&#xD;
        for digestive symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Ricerche Cliniche di Verona Srl,</name>
      <address>
        <city>Verona</city>
        <state>(Vr)</state>
        <zip>37100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>September 6, 2019</last_update_submitted>
  <last_update_submitted_qc>September 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lactoflorene plus</keyword>
  <keyword>Bifidobacterium animalis subsp. lactis, BB-12®</keyword>
  <keyword>Lactobacillus acidophilus, LA-5®</keyword>
  <keyword>Lactobacillus paracasei subsp. paracasei, L. CASEI 431®</keyword>
  <keyword>Inflammation</keyword>
  <keyword>gut permeability</keyword>
  <keyword>disbiosis</keyword>
  <keyword>probiotic</keyword>
  <keyword>IgA</keyword>
  <keyword>IL10</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
    <mesh_term>Dysbiosis</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/NCT03234452
org study id: Lactoflorene plus
nct id: NCT03234452
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in
      Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of
      inflammation and intestinal barrier function and gastrointestinal symptoms in healthy
      volunteers with self-reported anxiety.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double-blind
measure: NK activity
time frame: 45 days
description: Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
measure: IgA, IL8, TNF-Alpha, IL10
time frame: 45 days
measure: Cortisol, alpha-amylase , chromogranin A
time frame: 45 days
measure: microbiota composition investigation
time frame: 45 days
measure: Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
time frame: 45 days
arm group label: Lactoflorene plus
arm group type: Experimental
description: 10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day
arm group label: Placebo Lactoflorene plus
arm group type: Placebo Comparator
description: Identical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling.
intervention type: Dietary Supplement
intervention name: Lactoflorene plus
description: 2 vials with dosing cap (10 mL) a day per os
arm group label: Lactoflorene plus
intervention type: Dietary Supplement
intervention name: Placebo Lactoflorene plus
description: 2 vials with dosing cap (10 mL) a day per os
arm group label: Placebo Lactoflorene plus
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Constipation
mesh term: Diarrhea
mesh term: Abdominal Pain
mesh term: Dysbiosis
sharing ipd: No