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/NCT06035835</url>
    </required_header>
    <id_info>
      <org_study_id>BM-2022-12-0144.R2</org_study_id>
      <nct_id>NCT06035835</nct_id>
    </id_info>
    <brief_title>Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants</brief_title>
    <official_title>Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>José Uberos Fernández</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Clinico Universitario San Cecilio</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is assess if the use of probiotic in very low weight could be other&#xD;
        benefits a long time, as reduce atopic disease in this children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigators analyse the influence of nutrition during the early neonatal&#xD;
        period on the development and prevention of atopic dermatitis (AD) in children with a history&#xD;
        of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm&#xD;
        infants to assess the risk of their developing AD during childhood, according to nutrition&#xD;
        with breastmilk and/or probiotic supplementation during the neonatal period. The analysis&#xD;
        focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184&#xD;
        received probiotics up to 36 weeks postmenstrual age.&#xD;
  &#xD;
        The neonatal history of the patients was consulted in their electronic medical records&#xD;
        (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual&#xD;
        age; nutricional management; administration of probiotics), and the presence of atopic&#xD;
        diseases at school age was corroborated by telephone interviews.&#xD;
  &#xD;
        The descriptive date were summarized using medians and interquartile intervals for the&#xD;
        continuous variables and distribution frequencies for the categorial variables. Univariate&#xD;
        comparisons were made by the Mann-Whitney test for the continuous variables and by the&#xD;
        chi-square test for the categorical variables. The association of comorbidities in VLBW&#xD;
        newborns and supplementation with one type or another of probiotic was evaluated with a&#xD;
        multinomial regression analysis, ajustando por las variables que mostraron diferencias en el&#xD;
        análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS&#xD;
        20.0 for Windows software&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2009</start_date>
    <completion_date type="Actual">March 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change incidence of atopic dermatitis in children receiving probiotics</measure>
      <time_frame>From birth to January 2023</time_frame>
      <description>The investigators will assess the presence of atopic dermatitis (itching and chronic or recurrent eczematous lesions with typical morphology and distribution) in the telephone interview.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children.</measure>
      <time_frame>From birth to January 2023</time_frame>
      <description>The investigators will ask patients for both attopic dermatitis involvement and a history of probiotic and breast milk administration in the neonatal period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Identify probiotic strains that may decrease the incidence of atopic dermatitis.</measure>
      <time_frame>From birth to January 2023</time_frame>
      <description>In the group of patients who received probiotics we found two groups, one group received Lacticaseibacillus rhamnosus ATCC 53103 and the other group received the combination of Lactobacillus acidophilus ATCC 4356 + Bifidobacterium bifidum ATCC 15696. An attempt will be made to identify if there are differences between them.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Influence of caloric intake on the development of atopic dermatitis</measure>
      <time_frame>From birth to January 2023</time_frame>
      <description>The researchers will look at the medical history for caloric and macronutrient intake during the first weeks of life and assess whether it is related to differences in the development of atopic dermatitis.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">437</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>Probiotic 1</arm_group_label>
      <description>Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic 2</arm_group_label>
      <description>Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No probiotic</arm_group_label>
      <description>No suplementation diet with probiotic</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Lacticaseibacillus rhamnosus</intervention_name>
      <description>Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)</description>
      <arm_group_label>Probiotic 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Lactobacillus acidophilus + Bifidobacterium bifidum</intervention_name>
      <description>Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)</description>
      <arm_group_label>Probiotic 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Newborn with a gestational age &lt; or = 32 weeks and/or birth weight &lt; or = 1500 grams born&#xD;
          at our hospital (Hospital Universitario Clínico San Cecilio, Granada) between January 2009&#xD;
          and December 2021.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newborn with a gestational age &lt; or = 32 weeks and/or birth weight &lt; or = 1500 grams.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Incomplete health history record o lack of data.&#xD;
  &#xD;
            -  Severe congenital anomalies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>32 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>José Uberos-Fernández, Mr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Clinico Universitario San Cecilio</affiliation>
    </overall_official>
    <link>
      <url>https://www.seneo.es/images/site/publicaciones/libros/Nutricion_parenteral.pdf</url>
      <description>Uberos, J., Narbona, E., Gormaz, M., Lines, M., Rodríguez, G., Saenz de Pipaón, M. and Couce, M., 2017b. Nutrición parenteral en el recién nacido prematuro de muy bajo peso. Propuesta de un protocolo de actuación tras revisión de la evidencia científica.</description>
    </link>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Clinico Universitario San Cecilio</investigator_affiliation>
      <investigator_full_name>José Uberos Fernández</investigator_full_name>
      <investigator_title>Head of Unit Care Neonatology, Principal Investigator, Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Probiotics</keyword>
    <keyword>Human breastmilk</keyword>
    <keyword>newborn</keyword>
    <keyword>very low birth weight</keyword>
    <keyword>atopic eczema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 9, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT06035835/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06035835
  org study id: BM-2022-12-0144.R2
  nct id: NCT06035835
  lead sponsor: 
  has dmc: No
  The purpose of this study is assess if the use of probiotic in very low weight could be other
        benefits a long time, as reduce atopic disease in this children.
  In this study, the investigators analyse the influence of nutrition during the early neonatal
        period on the development and prevention of atopic dermatitis (AD) in children with a history
        of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm
        infants to assess the risk of their developing AD during childhood, according to nutrition
        with breastmilk and/or probiotic supplementation during the neonatal period. The analysis
        focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184
        received probiotics up to 36 weeks postmenstrual age.
  
        The neonatal history of the patients was consulted in their electronic medical records
        (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual
        age; nutricional management; administration of probiotics), and the presence of atopic
        diseases at school age was corroborated by telephone interviews.
  
        The descriptive date were summarized using medians and interquartile intervals for the
        continuous variables and distribution frequencies for the categorial variables. Univariate
        comparisons were made by the Mann-Whitney test for the continuous variables and by the
        chi-square test for the categorical variables. The association of comorbidities in VLBW
        newborns and supplementation with one type or another of probiotic was evaluated with a
        multinomial regression analysis, ajustando por las variables que mostraron diferencias en el
        análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS
        20.0 for Windows software
  observational model: Cohort
  time perspective: Retrospective
  measure: Change incidence of atopic dermatitis in children receiving probiotics
  time frame: From birth to January 2023
  description: The investigators will assess the presence of atopic dermatitis (itching and chronic or recurrent eczematous lesions with typical morphology and distribution) in the telephone interview.
  measure: To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children.
  time frame: From birth to January 2023
  description: The investigators will ask patients for both attopic dermatitis involvement and a history of probiotic and breast milk administration in the neonatal period.
  measure: Identify probiotic strains that may decrease the incidence of atopic dermatitis.
  time frame: From birth to January 2023
  description: In the group of patients who received probiotics we found two groups, one group received Lacticaseibacillus rhamnosus ATCC 53103 and the other group received the combination of Lactobacillus acidophilus ATCC 4356 + Bifidobacterium bifidum ATCC 15696. An attempt will be made to identify if there are differences between them.
  measure: Influence of caloric intake on the development of atopic dermatitis
  time frame: From birth to January 2023
  description: The researchers will look at the medical history for caloric and macronutrient intake during the first weeks of life and assess whether it is related to differences in the development of atopic dermatitis.
  arm group label: Probiotic 1
  description: Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age
  arm group label: Probiotic 2
  description: Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age
  arm group label: No probiotic
  description: No suplementation diet with probiotic
  intervention type: Combination Product
  intervention name: Lacticaseibacillus rhamnosus
  description: Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)
  arm group label: Probiotic 1
  intervention type: Combination Product
  intervention name: Lactobacillus acidophilus + Bifidobacterium bifidum
  description: Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)
  arm group label: Probiotic 2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 32 Weeks
  healthy volunteers: No
  last name: José Uberos-Fernández, Mr
  role: Principal Investigator
  affiliation: Hospital Clinico Universitario San Cecilio
  url: https://www.seneo.es/images/site/publicaciones/libros/Nutricion_parenteral.pdf
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  responsible party type: Sponsor-Investigator
  investigator affiliation: Hospital Clinico Universitario San Cecilio
  investigator full name: José Uberos Fernández
  investigator title: Head of Unit Care Neonatology, Principal Investigator, Clinical Professor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  sharing ipd: Undecided
  provided document: 