xml: <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/NCT05965063</url>
    </required_header>
    <id_info>
      <org_study_id>BifidobacteriumRJH</org_study_id>
      <nct_id>NCT05965063</nct_id>
    </id_info>
    <brief_title>The Role of Bifidobacterium Intervention in Food Allergic Infants</brief_title>
    <official_title>Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruijin Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Infant food protein allergy is the most common allergic disease in children, which can lead&#xD;
        to infantile-specific dermatitis, intestinal inflammation, and so on. Dietary avoidance is a&#xD;
        common strategy for food protein allergy in infants and young children. However, the hidden&#xD;
        etiology of food protein allergy or multiple food allergies often leads to poor efficacy. The&#xD;
        aim of this study is to observe the clinical effectiveness of Bifidobacterium intervention on&#xD;
        food allergy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The milk related symptom score at the 4th week</measure>
      <time_frame>Treatment for 4-week</time_frame>
      <description>Compare the clinical symptoms of infants at the 4th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The milk related symptom score at the 8th week</measure>
      <time_frame>Treatment for 8-week</time_frame>
      <description>Compare the clinical symptoms of infants at the 8th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The milk related symptom score at 12th week</measure>
      <time_frame>Treatment for 12-week</time_frame>
      <description>Compare the clinical symptoms of infants at the 12th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The percentile number of height at the 4th, 8th and12th week</measure>
      <time_frame>Treatment for 4-week, 8-week and 12-week</time_frame>
      <description>Compare the Percentile number of height of infants at the 4th, 8th and 12th week</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentile number of weight at the 4th, 8th and 12th week</measure>
      <time_frame>Treatment for 4-week, 8-week and 12-week</time_frame>
      <description>Compare the Percentile number of weight of infants at the 4th, 8th and 12th week</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentile number of head circumference at the 4th, 8th and 12th week</measure>
      <time_frame>Treatment for 4-week, 8-week and 12-week</time_frame>
      <description>Compare the Percentile number of head circumference of infants at the 4th, 8th and 12th week</description>
    </other_outcome>
    <other_outcome>
      <measure>The composition of intestinal microbiome</measure>
      <time_frame>Treatment for 4-week, 8-week and 12-week</time_frame>
      <description>All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics and composition of intestinal microbiome at the 4th, 8th and 12th week to analyze the intestinal microbiome composition</description>
    </other_outcome>
    <other_outcome>
      <measure>The composition of intestinal microbiome metabolites</measure>
      <time_frame>Treatment for 4-week, 8-week and 12-week</time_frame>
      <description>This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics at the 4th, 8th and 12th week to analyze the intestinal microbiome metabolites.</description>
    </other_outcome>
    <other_outcome>
      <measure>the messenger ribonucleic acid (mRNA) expression of blood</measure>
      <time_frame>Treatment for 12-week</time_frame>
      <description>The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Food Allergy in Infants</condition>
    <arm_group>
      <arm_group_label>Dietary avoidance for allergy food</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>strict avoidance of the specific allergenic food</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bifidobacterium intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>without intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Bifidobacterium M-16V</intervention_name>
      <description>Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.</description>
      <arm_group_label>bifidobacterium intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>allergy food avoidance</intervention_name>
      <description>strict avoidance of the specific allergenic food</description>
      <arm_group_label>Dietary avoidance for allergy food</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  0 -12 months infant&#xD;
  &#xD;
            -  Infants that are allergic (confirmed by an allergist) to at least one of the main food&#xD;
               allergens (cow's milk, egg, soy or wheat) and is following an elimination diet to at&#xD;
               least one of these allergens.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients had used probiotics within 1 month prior to the study&#xD;
  &#xD;
            -  Allergy or intolerance to probiotics or their excipient&#xD;
  &#xD;
            -  Serious primary diseases of the cardiovascular, nervous, respiratory,hepatobiliary&#xD;
               immunology，and endocrine systems;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Months</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>CHUNDI Xu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ruijin Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>XINQIONG WANG</last_name>
      <phone>0086-021-64370045</phone>
      <phone_ext>600905</phone_ext>
      <email>wxq11671@rjh.com.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yi Yu</last_name>
      <phone>0086-021-64370045</phone>
      <phone_ext>600905</phone_ext>
      <email>yy11635@rjh.com.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>021</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Food Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965063
  org study id: BifidobacteriumRJH
  nct id: NCT05965063
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Infant food protein allergy is the most common allergic disease in children, which can lead
        to infantile-specific dermatitis, intestinal inflammation, and so on. Dietary avoidance is a
        common strategy for food protein allergy in infants and young children. However, the hidden
        etiology of food protein allergy or multiple food allergies often leads to poor efficacy. The
        aim of this study is to observe the clinical effectiveness of Bifidobacterium intervention on
        food allergy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The milk related symptom score at the 4th week
  time frame: Treatment for 4-week
  description: Compare the clinical symptoms of infants at the 4th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
  measure: The milk related symptom score at the 8th week
  time frame: Treatment for 8-week
  description: Compare the clinical symptoms of infants at the 8th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
  measure: The milk related symptom score at 12th week
  time frame: Treatment for 12-week
  description: Compare the clinical symptoms of infants at the 12th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
  measure: The percentile number of height at the 4th, 8th and12th week
  time frame: Treatment for 4-week, 8-week and 12-week
  description: Compare the Percentile number of height of infants at the 4th, 8th and 12th week
  measure: The percentile number of weight at the 4th, 8th and 12th week
  time frame: Treatment for 4-week, 8-week and 12-week
  description: Compare the Percentile number of weight of infants at the 4th, 8th and 12th week
  measure: The percentile number of head circumference at the 4th, 8th and 12th week
  time frame: Treatment for 4-week, 8-week and 12-week
  description: Compare the Percentile number of head circumference of infants at the 4th, 8th and 12th week
  measure: The composition of intestinal microbiome
  time frame: Treatment for 4-week, 8-week and 12-week
  description: All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics and composition of intestinal microbiome at the 4th, 8th and 12th week to analyze the intestinal microbiome composition
  measure: The composition of intestinal microbiome metabolites
  time frame: Treatment for 4-week, 8-week and 12-week
  description: This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics at the 4th, 8th and 12th week to analyze the intestinal microbiome metabolites.
  measure: the messenger ribonucleic acid (mRNA) expression of blood
  time frame: Treatment for 12-week
  description: The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week
  arm group label: Dietary avoidance for allergy food
  arm group type: Other
  description: strict avoidance of the specific allergenic food
  arm group label: bifidobacterium intervention
  arm group type: Experimental
  description: Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food
  arm group label: Healthy control
  arm group type: No Intervention
  description: without intervention
  intervention type: Dietary Supplement
  intervention name: Bifidobacterium M-16V
  description: Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.
  arm group label: bifidobacterium intervention
  intervention type: Other
  intervention name: allergy food avoidance
  description: strict avoidance of the specific allergenic food
  arm group label: Dietary avoidance for allergy food
  criteria: 
  gender: All
  minimum age: 0 Months
  maximum age: 12 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: CHUNDI Xu
  role: Principal Investigator
  affiliation: Ruijin Hospital
  last name: XINQIONG WANG
  phone: 0086-021-64370045
  phone ext: 600905
  email: wxq11671@rjh.com.cn
  last name: Yi Yu
  phone: 0086-021-64370045
  phone ext: 600905
  email: yy11635@rjh.com.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Food Hypersensitivity
  sharing ipd: No