<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/NCT03256370</url>
  </required_header>
  <id_info>
    <org_study_id>HMOs</org_study_id>
    <nct_id>NCT03256370</nct_id>
  </id_info>
  <brief_title>Association of HMOs and Allergic Manifestations</brief_title>
  <official_title>The Association Between Human Milk Oligosaccharide and Development of Allergic Manifestations in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <brief_summary>
    <textblock>
      Compare the HMO composition in breast milk of infants with allergic manifestation (atopic&#xD;
      dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic&#xD;
      mother and healthy infants with non-allergic mother.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Parents of breast-fed infant from general pediatric clinic and allergy clinic of King&#xD;
           Chulalongkorn Memorial Hospital were approached for informed about the research and ask&#xD;
           to join this project&#xD;
&#xD;
        -  After completed informed consent, demographic data was collected and filled in case&#xD;
           record form&#xD;
&#xD;
        -  Milk of mother in both allergic and control groups were collected 60 ml then transferred&#xD;
           to freeze at -80oc to for human milk oligosaccharide analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">October 5, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 5, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Atopic dermatitis</measure>
    <time_frame>first 2 years of life</time_frame>
    <description>Relapsing eczematous typical morphology on typical distribution (Scalp, face, neck, and extensor surfaces of the skin) Typical morphology Acute and subacute : erythematous papules and plaques, may vesiculate and become exudative Chronic : lichenification, papules and excoriations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IgE mediated food allergy</measure>
    <time_frame>first 2 years of life</time_frame>
    <description>confirmed by oral food challenge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-IgE mediated food allergy</measure>
    <time_frame>first 2 years of life</time_frame>
    <description>Presentation of clinical ex. bloody stool when repeating episode occurred with the same food more than twice. Improvement of symptom after eliminating of suspected food</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Human Milk Oligosaccharides, Allergic Manifestation</condition>
  <arm_group>
    <arm_group_label>Infants with allergic diseases</arm_group_label>
    <description>allergic disease : atopic dermatitis or food allergy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy infants with atopic mothers</arm_group_label>
    <description>atopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy infants with non-atopic mothers.</arm_group_label>
    <description>non-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>milk collection</intervention_name>
    <description>Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project&#xD;
After completed informed consent, demographic data was collected and filled in case record form&#xD;
Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis&#xD;
Method of human milk oligosaccharide analysis :&#xD;
Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method&#xD;
High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method</description>
    <arm_group_label>Healthy infants with atopic mothers</arm_group_label>
    <arm_group_label>Healthy infants with non-atopic mothers.</arm_group_label>
    <arm_group_label>Infants with allergic diseases</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      human breast-milk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal term children (born after 37 weeks gestation) from low risk healthy pregnant women&#xD;
        aged 18-40 years divided to 3 groups i. Allergic groups : infants with allergic&#xD;
        manifestation ii. High risk control groups : atopic mother with infant no disease iii.&#xD;
        Healthy control groups : non- atopic mother with infant no disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. mothers with breast-fed infant with or without allergic manifestation&#xD;
&#xD;
          2. Intend to participate for follow up and sign consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mothers with any medical illness or high risk infant pregnant&#xD;
&#xD;
          2. Infants with disease which affected allergic disease&#xD;
&#xD;
          3. No inform consent&#xD;
&#xD;
          4. Anything in the opinion of the investigator that would prevent children from&#xD;
             completing the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Narissara Suratannon, MD</last_name>
    <phone>662-256-4933</phone>
    <email>narissara.su@chula.ac.th</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jintana Chataroopwijit, MD</last_name>
    <email>Drjintana43@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chulalongkorn University</name>
      <address>
        <city>Pathum Wan</city>
        <state>Bangkok</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Narissara Suratannon, MD</last_name>
      <phone>668-1295-0190</phone>
      <email>narissara.su@chula.ac.th</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 15, 2017</last_update_submitted>
  <last_update_submitted_qc>October 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergic manifestation, Human milk oligosaccharides, Breast Milk</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256370
org study id: HMOs
nct id: NCT03256370
lead sponsor: 
Compare the HMO composition in breast milk of infants with allergic manifestation (atopic
      dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic
      mother and healthy infants with non-allergic mother.
-  Parents of breast-fed infant from general pediatric clinic and allergy clinic of King
           Chulalongkorn Memorial Hospital were approached for informed about the research and ask
           to join this project

        -  After completed informed consent, demographic data was collected and filled in case
           record form

        -  Milk of mother in both allergic and control groups were collected 60 ml then transferred
           to freeze at -80oc to for human milk oligosaccharide analysis
observational model: Case-Control
time perspective: Prospective
measure: Atopic dermatitis
time frame: first 2 years of life
description: Relapsing eczematous typical morphology on typical distribution (Scalp, face, neck, and extensor surfaces of the skin) Typical morphology Acute and subacute : erythematous papules and plaques, may vesiculate and become exudative Chronic : lichenification, papules and excoriations
measure: IgE mediated food allergy
time frame: first 2 years of life
description: confirmed by oral food challenge
measure: Non-IgE mediated food allergy
time frame: first 2 years of life
description: Presentation of clinical ex. bloody stool when repeating episode occurred with the same food more than twice. Improvement of symptom after eliminating of suspected food
arm group label: Infants with allergic diseases
description: allergic disease : atopic dermatitis or food allergy
arm group label: Healthy infants with atopic mothers
description: atopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors)
arm group label: Healthy infants with non-atopic mothers.
description: non-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis
intervention type: Procedure
intervention name: milk collection
description: Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project
After completed informed consent, demographic data was collected and filled in case record form
Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis
Method of human milk oligosaccharide analysis :
Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method
arm group label: Healthy infants with atopic mothers
arm group label: Healthy infants with non-atopic mothers.
arm group label: Infants with allergic diseases
human breast-milk
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Narissara Suratannon, MD
phone: 662-256-4933
email: narissara.su@chula.ac.th
last name: Jintana Chataroopwijit, MD
email: Drjintana43@hotmail.com
facility: 
status: Recruiting
contact: 
country: Thailand
responsible party type: Sponsor
sharing ipd: Undecided