<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/NCT02239588</url>
  </required_header>
  <id_info>
    <org_study_id>13-SC-7-BRD-002</org_study_id>
    <nct_id>NCT02239588</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age</brief_title>
  <official_title>Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bright Dairy &amp; Food Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bright Dairy &amp; Food Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with&#xD;
      a 12-week intervention period.&#xD;
&#xD;
      The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6&#xD;
      months) milk powder on:&#xD;
&#xD;
        1. Bone health;&#xD;
&#xD;
        2. Infants growth;&#xD;
&#xD;
        3. Intestinal health;&#xD;
&#xD;
        4. Gastrointestinal tolerance to the test product;&#xD;
&#xD;
      g) Incidence of Eczema&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      • Quality control of the study: 1.1 Study monitoring and source data verification: Monitoring&#xD;
      was done according to the monitoring plan by a representative of the investigator, who&#xD;
      checked the case report forms for completeness and clarity, and cross-checked them with&#xD;
      source documents. In addition to the monitoring visits, frequent communications (letter,&#xD;
      telephone, fax, e-mail), by the study monitor ensured that the investigation was conducted&#xD;
      according to protocol design and regulatory requirements. Study close-out was performed by&#xD;
      the study monitor upon closure of the study.&#xD;
&#xD;
      1.2 On-site audits: Domestic and foreign regulatory authorities, the IEC/IRB, and an auditor&#xD;
      authorized by the sponsor may request access to all source documents, case report forms, and&#xD;
      other study documentation for on-site audit or inspection. Direct access to these documents&#xD;
      was guaranteed by the investigator, who must provide support at all times for these&#xD;
      activities. Medical records and other study documents may be copied during audit or&#xD;
      inspection provided that subject names are obliterated on the copies to ensure&#xD;
      confidentiality.&#xD;
&#xD;
      1.3 Documentation: A case report form was provided for each subject. All protocol-required&#xD;
      information collected during the study was entered by the investigator, or designated&#xD;
      representative, in the case report form. Details of case report form completion and&#xD;
      correction were explained to the investigator.&#xD;
&#xD;
      The investigator, or designated representative, should complete the case report form pages as&#xD;
      soon as possible after information is collected, preferably on the same day that a study&#xD;
      patient is seen for an examination, treatment, or any other study procedure. Any outstanding&#xD;
      entries must be completed immediately after the final examination. An explanation should be&#xD;
      given for all missing data.&#xD;
&#xD;
      A source data location list was prepared prior to study initiation. This list was filed in&#xD;
      both the trial master file and the investigator study file and updated as necessary.&#xD;
&#xD;
      The completed case report forms were reviewed and signed by the investigator named in the&#xD;
      clinical study protocol or by a designated sub investigator.&#xD;
&#xD;
      The sponsor would retain the original of all completed case report forms. The principal&#xD;
      investigator kept the copies of all completed case report forms for 25 years after the trial&#xD;
      based on Good Clinical Practice (GCP) requirements.&#xD;
&#xD;
      • Quality assurance of study products: All products used in this study were manufactured and&#xD;
      provided by Bright Dairy &amp; Food Co., Ltd. The quality test of study products was conducted by&#xD;
      Shanghai dairy products quality supervision and inspection station. The study products were&#xD;
      stored at the study site and assigned to the subjects by the investigator. The amount of&#xD;
      products received and assigned were filed on product distribution list by the investigator.&#xD;
      The study products were not allowed to be given to anyone who didn't participated in the&#xD;
      study. No sales of unassigned products was allowed. After the completion of the study, the&#xD;
      unassigned products need to be returned to Bright Dairy &amp; Food Co., Ltd.&#xD;
&#xD;
      The products were labeled with study code. A master participation list was completed which&#xD;
      identifies each patient full name and unique identification number. The identity of the&#xD;
      specific product was blind to patients, support staff and investigators. The unmasking&#xD;
      occurred to the investigators and statistical analyses team only after completion of&#xD;
      statistical analyses.&#xD;
&#xD;
      • Data management: Study data were recorded on Case Report Forms (CRFs) and then entered into&#xD;
      saved in the form of Excel files. Data was double entered and cross-validated.&#xD;
&#xD;
      • Management of subject withdrawal: A number of 120 subjects were enrolled in the study.&#xD;
&#xD;
      Subjects may be withdrawn from the study for the following reasons:&#xD;
&#xD;
        -  At their own request or at the request of their legally authorized representative,&#xD;
&#xD;
        -  If, in the investigator's opinion, continuation in the study would be detrimental to the&#xD;
           patient's well-being,&#xD;
&#xD;
        -  If they are lost to follow-up. In all cases, the reason for and date of withdrawal must&#xD;
           be recorded in the Exit Form and in the subject's medical records and the sponsor's&#xD;
           representative must be notified within 5 days. The subject must be followed up to&#xD;
           establish whether the reason was an adverse event, and, if so, this must be reported in&#xD;
           accordance with the procedure of an adverse event (described bellow). The investigator&#xD;
           must make every effort to contact subject lost to follow-up. Attempts to contact such&#xD;
           subject must be documented in the subject's records (e.g., dates and times of attempted&#xD;
           telephone contact).&#xD;
&#xD;
      Investigator must be notified of all serious or unexpected adverse events within 48 hours.&#xD;
      Notification does not depend on whether there is a connection to the study formula or not.&#xD;
      All adverse events must be documented on the appropriate pages of the case report forms.&#xD;
&#xD;
      • Statistical analysis plan: Analysis was performed for the intent-to-treat population.&#xD;
      Chi-square test was used comparison among study groups for categorical data. For continuous&#xD;
      outcomes, one-way ANOVA was used for between-group comparison, followed by multiple&#xD;
      comparison with Bonferroni adjustment. Paired t-test was used for pre-post comparison within&#xD;
      each study group. Non-parametric methods were used for non-normal data, data with unequal&#xD;
      variances. The analysis was completed using the statistical package SPSS17.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone density change from baseline (Tibial speed of sound measurement)</measure>
    <time_frame>After 12 weeks of study intervention</time_frame>
    <description>Week 12 values minus Baseline (week 0) values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth measurements</measure>
    <time_frame>Baseline (week 0), week 4, week 8, week 12</time_frame>
    <description>Body weight (g), Height (cm), Head circumference (cm), Chest circumference (cm),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>Daily up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal short-chain fatty acid concentration</measure>
    <time_frame>Baseline (week 0), week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal bacteria count</measure>
    <time_frame>Baseline (week 0), week 12</time_frame>
    <description>Bifidobacteria Lactobacteria Clostridium perfringens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal adherence questionnaire</measure>
    <time_frame>Daily up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Eczema</measure>
    <time_frame>Baseline (week 0), week 4, week 8, week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Daily up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Growth Acceleration</condition>
  <arm_group>
    <arm_group_label>Pure Canterbury milk powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral consumption of infant formula (0-6 months) milk powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other infant formula milk powder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral consumption of milk powder (other than the experimental product) selected by subjects' parents. The products including:&#xD;
Yashili Ambery Infant Formula Milk Powder (Stage 1: 0-6 months)&#xD;
Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast milk</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral consumption of breast milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral consumption</intervention_name>
    <description>Daily oral consumption for 12 weeks:&#xD;
Placebo;&#xD;
Pure Canterbury;&#xD;
Other infant formula milk powder:&#xD;
Yashili Ambery Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)&#xD;
Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)</description>
    <arm_group_label>Breast milk</arm_group_label>
    <arm_group_label>Other infant formula milk powder</arm_group_label>
    <arm_group_label>Pure Canterbury milk powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants 7~90 days old;&#xD;
&#xD;
          -  Fed by breast milk before enrollment;&#xD;
&#xD;
          -  Concent form signed by parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Twins, multiple births, low birth weight children, over birth weight children or early&#xD;
             birth children with gestational age less than 37 weeks;&#xD;
&#xD;
          -  During pregnancy, the mothers had pregnancy complications or other disease that may&#xD;
             affect the study results;&#xD;
&#xD;
          -  Having serious diseases that may affect study interventions, such as neonatal sepsis,&#xD;
             pneumonia (associated with respiratory failure), heart failure and other diseases;&#xD;
&#xD;
          -  Having neonatal diarrhea or acute respiratory infections within 48 hours before&#xD;
             enrollment;&#xD;
&#xD;
          -  Having potential metabolic diseases, chronic diseases, congenital malformations,&#xD;
             central nervous system disorders, neuromuscular disorders or diseases affecting bone&#xD;
             metabolism that may affect growth or the study results;&#xD;
&#xD;
          -  Having taken any food containing prebiotics or probiotics within 15 days of&#xD;
             enrollment;&#xD;
&#xD;
          -  Having gluten allergy (celiac disease);&#xD;
&#xD;
          -  Body weight-to-height Z-value &lt;-3 according to the standard of WHO;&#xD;
&#xD;
          -  Receiving hormone therapy and intravenous nutrition;&#xD;
&#xD;
          -  Lactose intolerance;&#xD;
&#xD;
          -  Have participated in other clinical studies within 3 months prior to the date of&#xD;
             screening;&#xD;
&#xD;
          -  Unable to comply the study schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>90 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoyang Sheng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>XinHua Hospital Affiliated to Shanghai JiaoTong University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02239588
org study id: 13-SC-7-BRD-002
nct id: NCT02239588
lead sponsor: 
has dmc: Yes
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with
      a 12-week intervention period.

      The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6
      months) milk powder on:

        1. Bone health;

        2. Infants growth;

        3. Intestinal health;

        4. Gastrointestinal tolerance to the test product;

      g) Incidence of Eczema
• Quality control of the study: 1.1 Study monitoring and source data verification: Monitoring
      was done according to the monitoring plan by a representative of the investigator, who
      checked the case report forms for completeness and clarity, and cross-checked them with
      source documents. In addition to the monitoring visits, frequent communications (letter,
      telephone, fax, e-mail), by the study monitor ensured that the investigation was conducted
      according to protocol design and regulatory requirements. Study close-out was performed by
      the study monitor upon closure of the study.

      1.2 On-site audits: Domestic and foreign regulatory authorities, the IEC/IRB, and an auditor
      authorized by the sponsor may request access to all source documents, case report forms, and
      other study documentation for on-site audit or inspection. Direct access to these documents
      was guaranteed by the investigator, who must provide support at all times for these
      activities. Medical records and other study documents may be copied during audit or
      inspection provided that subject names are obliterated on the copies to ensure
      confidentiality.

      1.3 Documentation: A case report form was provided for each subject. All protocol-required
      information collected during the study was entered by the investigator, or designated
      representative, in the case report form. Details of case report form completion and
      correction were explained to the investigator.

      The investigator, or designated representative, should complete the case report form pages as
      soon as possible after information is collected, preferably on the same day that a study
      patient is seen for an examination, treatment, or any other study procedure. Any outstanding
      entries must be completed immediately after the final examination. An explanation should be
      given for all missing data.

      A source data location list was prepared prior to study initiation. This list was filed in
      both the trial master file and the investigator study file and updated as necessary.

      The completed case report forms were reviewed and signed by the investigator named in the
      clinical study protocol or by a designated sub investigator.

      The sponsor would retain the original of all completed case report forms. The principal
      investigator kept the copies of all completed case report forms for 25 years after the trial
      based on Good Clinical Practice (GCP) requirements.

      • Quality assurance of study products: All products used in this study were manufactured and
      provided by Bright Dairy & Food Co., Ltd. The quality test of study products was conducted by
      Shanghai dairy products quality supervision and inspection station. The study products were
      stored at the study site and assigned to the subjects by the investigator. The amount of
      products received and assigned were filed on product distribution list by the investigator.
      The study products were not allowed to be given to anyone who didn't participated in the
      study. No sales of unassigned products was allowed. After the completion of the study, the
      unassigned products need to be returned to Bright Dairy & Food Co., Ltd.

      The products were labeled with study code. A master participation list was completed which
      identifies each patient full name and unique identification number. The identity of the
      specific product was blind to patients, support staff and investigators. The unmasking
      occurred to the investigators and statistical analyses team only after completion of
      statistical analyses.

      • Data management: Study data were recorded on Case Report Forms (CRFs) and then entered into
      saved in the form of Excel files. Data was double entered and cross-validated.

      • Management of subject withdrawal: A number of 120 subjects were enrolled in the study.

      Subjects may be withdrawn from the study for the following reasons:

        -  At their own request or at the request of their legally authorized representative,

        -  If, in the investigator's opinion, continuation in the study would be detrimental to the
           patient's well-being,

        -  If they are lost to follow-up. In all cases, the reason for and date of withdrawal must
           be recorded in the Exit Form and in the subject's medical records and the sponsor's
           representative must be notified within 5 days. The subject must be followed up to
           establish whether the reason was an adverse event, and, if so, this must be reported in
           accordance with the procedure of an adverse event (described bellow). The investigator
           must make every effort to contact subject lost to follow-up. Attempts to contact such
           subject must be documented in the subject's records (e.g., dates and times of attempted
           telephone contact).

      Investigator must be notified of all serious or unexpected adverse events within 48 hours.
      Notification does not depend on whether there is a connection to the study formula or not.
      All adverse events must be documented on the appropriate pages of the case report forms.

      • Statistical analysis plan: Analysis was performed for the intent-to-treat population.
      Chi-square test was used comparison among study groups for categorical data. For continuous
      outcomes, one-way ANOVA was used for between-group comparison, followed by multiple
      comparison with Bonferroni adjustment. Paired t-test was used for pre-post comparison within
      each study group. Non-parametric methods were used for non-normal data, data with unequal
      variances. The analysis was completed using the statistical package SPSS17.0.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Bone density change from baseline (Tibial speed of sound measurement)
time frame: After 12 weeks of study intervention
description: Week 12 values minus Baseline (week 0) values
measure: Growth measurements
time frame: Baseline (week 0), week 4, week 8, week 12
description: Body weight (g), Height (cm), Head circumference (cm), Chest circumference (cm),
measure: Stool consistency
time frame: Daily up to 12 weeks
measure: Fecal short-chain fatty acid concentration
time frame: Baseline (week 0), week 12
measure: Fecal bacteria count
time frame: Baseline (week 0), week 12
description: Bifidobacteria Lactobacteria Clostridium perfringens
measure: Intestinal adherence questionnaire
time frame: Daily up to 12 weeks
measure: Incidence of Eczema
time frame: Baseline (week 0), week 4, week 8, week 12
measure: Adverse event
time frame: Daily up to 12 weeks
arm group label: Pure Canterbury milk powder
arm group type: Experimental
description: Oral consumption of infant formula (0-6 months) milk powder
arm group label: Other infant formula milk powder
arm group type: Active Comparator
description: Oral consumption of milk powder (other than the experimental product) selected by subjects' parents. The products including:
Yashili Ambery Infant Formula Milk Powder (Stage 1: 0-6 months)
Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)
Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)
Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)
Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)
Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)
arm group label: Breast milk
arm group type: Placebo Comparator
description: Oral consumption of breast milk
intervention type: Other
intervention name: Oral consumption
description: Daily oral consumption for 12 weeks:
Placebo;
Pure Canterbury;
Other infant formula milk powder:
Yashili Ambery Infant Formula Milk Powder (Stage 1 0-6 months)
Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)
Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)
Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)
Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)
Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)
arm group label: Breast milk
arm group label: Other infant formula milk powder
arm group label: Pure Canterbury milk powder
criteria: 
gender: All
minimum age: 7 Days
maximum age: 90 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaoyang Sheng, MD
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Sponsor