<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/NCT01677702</url>
  </required_header>
  <id_info>
    <org_study_id>YL/CL-002</org_study_id>
    <nct_id>NCT01677702</nct_id>
  </id_info>
  <brief_title>Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization</brief_title>
  <official_title>The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization</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>
      The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective&#xD;
      in reducing the occurrence of flu symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">July 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>Assess occurrence of flu symptoms during intervention</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess severity of flu symptoms</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects which require treatment with flu medication</measure>
    <time_frame>3 months</time_frame>
  </secondary_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>Record subject sick leave due to flu</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Immunization</condition>
  <condition>Human Influenza</condition>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recombined low-protein milk</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Total 250mL placebo milk will 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 Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)</intervention_name>
    <description>Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.</description>
    <arm_group_label>Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)</intervention_name>
    <description>Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.</description>
    <arm_group_label>Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Recombined low protein milk</intervention_name>
    <description>Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.</description>
    <arm_group_label>Recombined low-protein milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 6 to 12 years, catch cold for 4 to 6 times in last year;&#xD;
&#xD;
          -  Age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month;&#xD;
&#xD;
          -  Age 60 to 75 years, catch cold for 4 to 6 times in last year;&#xD;
&#xD;
          -  BMI 18.5to 29.9kg/m2;&#xD;
&#xD;
          -  Able to understand the nature and purpose of the study including potential risks and&#xD;
             side effects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent (within 6 months of screening) been vaccinated influenza vaccine, or recent&#xD;
             (within 15 days of screening) been vaccinated ther vaccines;&#xD;
&#xD;
          -  Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu&#xD;
             symptoms. Such as chronic allergic rhinitis, asthma, COPD;&#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;
          -  Known allergies to dairy and any substance in the study product;&#xD;
&#xD;
          -  History of alcohol, drug, or medication abuse&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt;&#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>6 Years</minimum_age>
    <maximum_age>75 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>Donglian Cai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital of Shanghai, Nutriology Dept.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yeqing Shi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital of Shanghai, Rheumatology Dept.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NanMoFang Community Health Service Center</name>
      <address>
        <city>Chao Yang District</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JuQuan Community Health Service Center</name>
      <address>
        <city>GuCun, 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 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactoferrin</mesh_term>
  </intervention_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/NCT01677702
org study id: YL/CL-002
nct id: NCT01677702
lead sponsor: 
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective
      in reducing the occurrence of flu symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Assess occurrence of flu symptoms during intervention
time frame: 3 months
measure: Assess severity of flu symptoms
time frame: 3 months
measure: Proportion of subjects which require treatment with flu medication
time frame: 3 months
measure: Change in immune markers such as antibodies and interleukins
time frame: Baseline & 3 months
measure: Record subject sick leave due to flu
time frame: 3 months
arm group label: Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)
arm group type: Active Comparator
description: Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
arm group label: Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)
arm group type: Active Comparator
description: Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
arm group label: Recombined low-protein milk
arm group type: Placebo Comparator
description: Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
intervention type: Dietary Supplement
intervention name: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)
description: Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
arm group label: Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)
intervention type: Dietary Supplement
intervention name: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
description: Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
arm group label: Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)
intervention type: Dietary Supplement
intervention name: Recombined low protein milk
description: Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
arm group label: Recombined low-protein milk
criteria: 
gender: All
minimum age: 6 Years
maximum age: 75 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: Donglian Cai
role: Principal Investigator
affiliation: Changhai Hospital of Shanghai, Nutriology Dept.
last name: Yeqing Shi
role: Principal Investigator
affiliation: Changhai Hospital of Shanghai, Rheumatology Dept.
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Influenza, Human
mesh term: Lactoferrin