<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/NCT01677715</url>
  </required_header>
  <id_info>
    <org_study_id>YL/CL-003</org_study_id>
    <nct_id>NCT01677715</nct_id>
  </id_info>
  <brief_title>Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System</brief_title>
  <official_title>Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inner Mongolia Yili Industrial Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inner Mongolia Yili Industrial Group Co., Ltd</source>
  <brief_summary>
    <textblock>
      Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on&#xD;
      Immunity and Physical Intestinal Canal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in constipation condition</measure>
    <time_frame>Baseline &amp; 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess severity of flu symptoms</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in immune markers such as antibodies and interleukins</measure>
    <time_frame>Baseline &amp; 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gut resident flora</measure>
    <time_frame>Baseline &amp; 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Immunization</condition>
  <condition>Human Influenza</condition>
  <condition>Common Cold</condition>
  <condition>Constipation</condition>
  <condition>Dyspepsia</condition>
  <condition>Flatulence</condition>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Yili &quot;Mei Yi Tian&quot; lactobacillus drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100ml of Yili &quot;Mei Yi Tian&quot; active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>recombined milk drink contains no lactobacillus</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yili &quot;Mei Yi Tian&quot; active lactobacillus drink</intervention_name>
    <description>100ml of Yili &quot;Mei Yi Tian&quot; active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention</description>
    <arm_group_label>Yili &quot;Mei Yi Tian&quot; lactobacillus drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>recombined milk drink contains no lactobacillus</intervention_name>
    <description>100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention</description>
    <arm_group_label>recombined milk drink contains no lactobacillus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year,&#xD;
             with low immunity;&#xD;
&#xD;
          -  Non-specific and/or moderate constipation;&#xD;
&#xD;
          -  Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling&#xD;
             heavy after eating, abdominal pain);&#xD;
&#xD;
          -  Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements&#xD;
             decreased, e.g. every 2-3 days or less than 3 times per week);&#xD;
&#xD;
          -  Able to understand the nature and purpose of the study including potential risks and&#xD;
             side effects;&#xD;
&#xD;
          -  Willing to consent to study participation and to comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as immunity-low associated with chronic disease;&#xD;
&#xD;
          -  Diagnosed as chronic constipation;&#xD;
&#xD;
          -  Treated gastrointestinal symptoms;&#xD;
&#xD;
          -  Currently suffering from diarrhea;&#xD;
&#xD;
          -  Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu&#xD;
             symptoms. Such as chronic allergic rhinitis, asthma, COPD;&#xD;
&#xD;
          -  Treatment by analgesic such as aspirin and paracetamol;&#xD;
&#xD;
          -  Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;&#xD;
&#xD;
          -  Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the&#xD;
             study start;&#xD;
&#xD;
          -  Long-term use of any prescription or OTC medication that inhibit or prevent flu&#xD;
             symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin&#xD;
             C;&#xD;
&#xD;
          -  Recent use (within 3 months of screening) of any prescription or OTC medication that&#xD;
             significantly affects immune response, such as antibiotic;&#xD;
&#xD;
          -  Recent inoculation (within 6 months of screening) of influenza vaccine, or other&#xD;
             vaccine in 15 days;&#xD;
&#xD;
          -  History of alcohol, drug, or medication abuse;&#xD;
&#xD;
          -  Pregnant or breastfeeding women;&#xD;
&#xD;
          -  Participation in another study with any investigational product within 3 months of&#xD;
             screening&#xD;
&#xD;
          -  Any comorbidity that could, in the opinion of the investigator, preclude the subject's&#xD;
             ability to successfully and safely complete the study or that may confound study&#xD;
             outcomes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying An, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Inner Mongolia Hilo Industrial Group Co., Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leiming Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gengru Jiang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NanMoFang Community Health Service Center</name>
      <address>
        <city>ChaoYang District</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Municipal Food and Drug Administration Baoshan Office</name>
      <address>
        <city>Baoshan District</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</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>Common Cold</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
    <mesh_term>Flatulence</mesh_term>
  </condition_browse>
  <!-- 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/NCT01677715
org study id: YL/CL-003
nct id: NCT01677715
lead sponsor: 
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on
      Immunity and Physical Intestinal Canal
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in constipation condition
time frame: Baseline & 3 months
measure: Assess severity of flu symptoms
time frame: 3 months
measure: Change in immune markers such as antibodies and interleukins
time frame: Baseline & 3 months
measure: Change in gut resident flora
time frame: Baseline & 3 months
arm group label: Yili "Mei Yi Tian" lactobacillus drink
arm group type: Active Comparator
description: 100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
arm group label: recombined milk drink contains no lactobacillus
arm group type: Placebo Comparator
description: 100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
intervention type: Dietary Supplement
intervention name: Yili "Mei Yi Tian" active lactobacillus drink
description: 100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
arm group label: Yili "Mei Yi Tian" lactobacillus drink
intervention type: Dietary Supplement
intervention name: recombined milk drink contains no lactobacillus
description: 100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
arm group label: recombined milk drink contains no lactobacillus
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ying An, Ph.D
role: Study Director
affiliation: Inner Mongolia Hilo Industrial Group Co., Ltd
last name: Leiming Xu
role: Principal Investigator
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
last name: Gengru Jiang
role: Principal Investigator
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Influenza, Human
mesh term: Constipation
mesh term: Dyspepsia
mesh term: Abdominal Pain
mesh term: Flatulence