<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/NCT01682798</url>
  </required_header>
  <id_info>
    <org_study_id>YL/LC-001</org_study_id>
    <nct_id>NCT01682798</nct_id>
  </id_info>
  <brief_title>Study of Yili &quot;Changqing&quot; Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System</brief_title>
  <official_title>The Clinical Research on the Efficiency of Yili &quot;Changqing&quot; Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System</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 &quot;Chang Qing&quot; Pro-ABB yoghurt is&#xD;
      effective in improving mild constipation and the intestinal micro-ecology environment &amp;&#xD;
      alimentation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">July 2009</completion_date>
  <primary_completion_date type="Actual">June 2009</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 after 3 weeks</measure>
    <time_frame>Baseline &amp; 3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gut resident flora after 3 weeks</measure>
    <time_frame>Baseline &amp; 3 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Constipation</condition>
  <condition>Dyspepsia</condition>
  <condition>Flatulence</condition>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100g of Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 1) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo yoghurt</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100g of Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 2) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo yoghurt</intervention_name>
    <description>100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.</description>
    <arm_group_label>Placebo yoghurt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 1)</intervention_name>
    <description>100g of Yili &quot;Chang Qing&quot; Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.</description>
    <arm_group_label>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 2)</intervention_name>
    <arm_group_label>Yili &quot;Chang Qing&quot; Pro-ABB yoghurt (Formula 2)</arm_group_label>
    <other_name>100g of Yili &quot;Chang Qing&quot; Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects, 25-45 yrs;&#xD;
&#xD;
          2. Non-specific and/or moderate constipation;&#xD;
&#xD;
          3. Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling&#xD;
             heavy after eating, abdominal pain);&#xD;
&#xD;
          4. 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;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as chronic constipation;&#xD;
&#xD;
          2. Treated gastrointestinal symptoms;&#xD;
&#xD;
          3. Lactose Intolerance;&#xD;
&#xD;
          4. Treatment by analgesic such as aspirin and paracetamol;&#xD;
&#xD;
          5. Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;&#xD;
&#xD;
          6. Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the&#xD;
             study start;&#xD;
&#xD;
          7. Currently suffering from diarrhea.&#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>Donglian Cai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital of Shanghai, Nutriology Dept.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xinwang Gao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine 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>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>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 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>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/NCT01682798
org study id: YL/LC-001
nct id: NCT01682798
lead sponsor: 
The purpose of this study is to determine whether Yili "Chang Qing" Pro-ABB yoghurt is
      effective in improving mild constipation and the intestinal micro-ecology environment &
      alimentation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in constipation condition after 3 weeks
time frame: Baseline & 3 weeks
measure: Change in gut resident flora after 3 weeks
time frame: Baseline & 3 Weeks
arm group label: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
arm group type: Active Comparator
description: 100g of Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
arm group label: Placebo yoghurt
arm group type: Placebo Comparator
description: 100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
arm group label: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
arm group type: Active Comparator
description: 100g of Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
intervention type: Dietary Supplement
intervention name: Placebo yoghurt
description: 100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
arm group label: Placebo yoghurt
intervention type: Dietary Supplement
intervention name: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
description: 100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
arm group label: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
intervention type: Dietary Supplement
intervention name: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
arm group label: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
other name: 100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
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: Donglian Cai
role: Principal Investigator
affiliation: Changhai Hospital of Shanghai, Nutriology Dept.
last name: Xinwang Gao
role: Principal Investigator
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Constipation
mesh term: Dyspepsia
mesh term: Abdominal Pain
mesh term: Flatulence