<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/NCT01724203</url>
  </required_header>
  <id_info>
    <org_study_id>111104-SUS-FON-ICP-MS</org_study_id>
    <nct_id>NCT01724203</nct_id>
  </id_info>
  <brief_title>Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.</brief_title>
  <official_title>Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months: a Double-blind, Randomized, Placebo-controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fonterra Research Centre</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sprim Advanced Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fonterra Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week&#xD;
      probiotic supplementation on the incidence and duration of infectious episodes in infants&#xD;
      aged 6 to 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Probiotics are live bacteria that offer a health benefit to the host when administered via&#xD;
      the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the&#xD;
      elderly and has demonstrated beneficial effects for a wide variety of health conditions such&#xD;
      as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease.&#xD;
      The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group&#xD;
      that is particularly prone to a variety of infections, e.g. respiratory tract infection,&#xD;
      strep throat, and diarrhea. Probiotic supplementation has been utilized in previous studies&#xD;
      of childhood infections with promising results.&#xD;
&#xD;
      In this study, the safety and effectiveness of 12-week probiotic supplementation on the&#xD;
      incidence and duration of infectious episodes in infants aged 6 to 12 months will be&#xD;
      determined. The subjects will receive follow-on formula containing 1 million CFU/g&#xD;
      Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis&#xD;
      subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day&#xD;
      for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever &gt; 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative days with infectious symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cumulative number of days with infectious symptoms will be defined as the total number of days during the study on which a subject has symptoms of a confirmed infection. Confirmed infections that count toward the primary endpoint include: fever &gt;37.5°C (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative number of infectious episodes</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cumulative number of infectious episodes will be defined as the total number of infectious episodes (defined as presence of one of more symptoms of a confirmed infection) experienced during the study. An infectious episode will be defined as a period when symptoms of a confirmed infection last for more than 24 hours and are followed by at least 3 days of no symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool frequency</measure>
    <time_frame>12 weeks</time_frame>
    <description>Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool Consistency</measure>
    <time_frame>12 weeks</time_frame>
    <description>Parents will rate the consistency of each infant bowel movement by using the Bristol Stool Scale Form. Parents will record stool consistency each day during the 12-week supplementation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Characteristics Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Infant Characteristic Questionnaire for infants approximately 6 months old (ICQ-6) measures parental perception of infant temperament, focusing on difficult temperament 8. The questionnaire is comprised of 24 items describing infant behavior. The parent or primary caregiver ranks each item on a 7-point scale, indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatments for infectious episodes</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Effect of Probiotics on Infections in Infants.</condition>
  <arm_group>
    <arm_group_label>Lactobacillus rhamnosus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bifidobacterium animalis subsp. lactis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo formula without probiotics at least three times daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus rhamnosus</intervention_name>
    <arm_group_label>Lactobacillus rhamnosus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bifidobacterium animalis subsp. lactis</intervention_name>
    <arm_group_label>Bifidobacterium animalis subsp. lactis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 6 to 12 months.&#xD;
&#xD;
          -  Known vaccination history.&#xD;
&#xD;
          -  Ability of the participant's parent or legal guardian to comprehend the full nature&#xD;
             and purpose of the study including possible risks and side effects.&#xD;
&#xD;
          -  Parental or legal guardian's consent to the study and willing to comply with study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms of any infection at screening.&#xD;
&#xD;
          -  History of ≥5 infections in the previous 2 months.&#xD;
&#xD;
          -  Lactose intolerance or unable to drink milk.&#xD;
&#xD;
          -  Leukopenia or leukocytosis.&#xD;
&#xD;
          -  Immunodeficient or use of immunosuppressive drugs.&#xD;
&#xD;
          -  Use of antibiotic and anti-inflammatory medications within the last 2 weeks.&#xD;
&#xD;
          -  Use of products containing prebiotics or probiotics within the last 2 weeks.&#xD;
&#xD;
          -  Use of low-lactose or lactose-free infant or follow-on formula within the last 2&#xD;
             weeks.&#xD;
&#xD;
          -  Hepatitis B or C.&#xD;
&#xD;
          -  Medications or supplements that may affect subject safety or confound study outcomes&#xD;
             in the opinion of the investigator.&#xD;
&#xD;
          -  Medical conditions or diseases that may affect subject safety or confound study&#xD;
             results in the opinion of the investigator.&#xD;
&#xD;
          -  Participation in another study with any investigational product within 3 months of&#xD;
             screening.&#xD;
&#xD;
          -  Any other condition that, in the investigator's opinion, may preclude the subject's&#xD;
             ability to safely complete the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoyang Sheng, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>October 10, 2013</last_update_submitted>
  <last_update_submitted_qc>October 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotics for infants</keyword>
  <keyword>Bacterial and viral infections in infants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</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/NCT01724203
org study id: 111104-SUS-FON-ICP-MS
nct id: NCT01724203
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week
      probiotic supplementation on the incidence and duration of infectious episodes in infants
      aged 6 to 12 months.
Probiotics are live bacteria that offer a health benefit to the host when administered via
      the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the
      elderly and has demonstrated beneficial effects for a wide variety of health conditions such
      as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease.
      The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group
      that is particularly prone to a variety of infections, e.g. respiratory tract infection,
      strep throat, and diarrhea. Probiotic supplementation has been utilized in previous studies
      of childhood infections with promising results.

      In this study, the safety and effectiveness of 12-week probiotic supplementation on the
      incidence and duration of infectious episodes in infants aged 6 to 12 months will be
      determined. The subjects will receive follow-on formula containing 1 million CFU/g
      Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis
      subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day
      for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
time frame: 12 weeks
description: The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever > 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.
measure: Cumulative days with infectious symptoms
time frame: 12 weeks
description: Cumulative number of days with infectious symptoms will be defined as the total number of days during the study on which a subject has symptoms of a confirmed infection. Confirmed infections that count toward the primary endpoint include: fever >37.5°C (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.
measure: Cumulative number of infectious episodes
time frame: 12 weeks
description: Cumulative number of infectious episodes will be defined as the total number of infectious episodes (defined as presence of one of more symptoms of a confirmed infection) experienced during the study. An infectious episode will be defined as a period when symptoms of a confirmed infection last for more than 24 hours and are followed by at least 3 days of no symptoms.
measure: Stool frequency
time frame: 12 weeks
description: Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.
measure: Stool Consistency
time frame: 12 weeks
description: Parents will rate the consistency of each infant bowel movement by using the Bristol Stool Scale Form. Parents will record stool consistency each day during the 12-week supplementation period.
measure: Infant Characteristics Questionnaire
time frame: 12 weeks
description: The Infant Characteristic Questionnaire for infants approximately 6 months old (ICQ-6) measures parental perception of infant temperament, focusing on difficult temperament 8. The questionnaire is comprised of 24 items describing infant behavior. The parent or primary caregiver ranks each item on a 7-point scale, indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable.
measure: Treatments for infectious episodes
time frame: 12 weeks
description: Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.
measure: Adverse events
time frame: 12 weeks
description: Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.
arm group label: Lactobacillus rhamnosus
arm group type: Active Comparator
description: Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.
arm group label: Bifidobacterium animalis subsp. lactis
arm group type: Active Comparator
description: Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo formula without probiotics at least three times daily for 12 weeks.
intervention type: Dietary Supplement
intervention name: Lactobacillus rhamnosus
arm group label: Lactobacillus rhamnosus
intervention type: Dietary Supplement
intervention name: Bifidobacterium animalis subsp. lactis
arm group label: Bifidobacterium animalis subsp. lactis
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaoyang Sheng, Dr
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases