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/NCT05986539</url>
    </required_header>
    <id_info>
      <org_study_id>23-013</org_study_id>
      <nct_id>NCT05986539</nct_id>
    </id_info>
    <brief_title>Early Life Feeding Exposure and Infant Immune and Health Status.</brief_title>
    <official_title>Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Idaho</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Idaho</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Although breastfeeding has known protective effects, such as preventing childhood&#xD;
        obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation&#xD;
        rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese).&#xD;
        Limited research exists on the impact of maternal inflammation, maternal body mass index&#xD;
        (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on&#xD;
        infant health outcomes, especially in healthy full-term infants.&#xD;
  &#xD;
        Objective: This study aims to expand understanding of the role of maternal inflammation on&#xD;
        breastmilk composition and its effect on infant immune development. The investigators seek to&#xD;
        investigate the relationship between maternal health status, breastmilk inflammatory&#xD;
        concentrations, and balanced immune development in infants. Additionally, the investigators&#xD;
        aim to explore the potential influence of early diet exposure, including maternal&#xD;
        inflammatory status, on the risk of obesity and other inflammatory conditions.&#xD;
  &#xD;
        Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be&#xD;
        recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will&#xD;
        be analyzed. Flow cytometry will assess immune populations. Correlations between maternal&#xD;
        systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be&#xD;
        examined for breastfeeding mothers.&#xD;
  &#xD;
        Outcomes: The investigators hypothesize breastfed infants will display a more favorable&#xD;
        anti-inflammatory profile. This study will identify factors influencing immune development&#xD;
        and potential pathways linking early-life exposures to long-term health outcomes. Findings&#xD;
        will inform strategies for promoting balanced immune development and elucidate the role of&#xD;
        early diet exposure, including maternal inflammation, as a protective or risk factor for&#xD;
        obesity and inflammatory conditions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The immune system of newborns is immature and undergoes rapid development during the first&#xD;
        few months of life. Inflammation is a natural response to infection or tissue injury, but&#xD;
        excessive or prolonged inflammation can be detrimental to immune development. Understanding&#xD;
        the relationship between inflammation and immune development in healthy full-term infants is&#xD;
        critical to developing effective interventions to promote healthy immune function in early&#xD;
        life.&#xD;
  &#xD;
        This project will collect blood samples from healthy full-term infants at 2 and 4 months of&#xD;
        age. The samples will be analyzed using flow cytometry to quantify the proportions and&#xD;
        activation status of different immune cell populations, such as T, B, natural killer, and&#xD;
        monocytes. The analysis will also include quantifying intracellular cytokines to assess the&#xD;
        functional capacity of the immune cells. The samples will be analyzed using established&#xD;
        methods to measure biomarkers of inflammation, such as CRP, TNF-alpha, and other inflammatory&#xD;
        interleukins and cytokines. This project will expand upon biomarkers previously examined to&#xD;
        aid in the overall understanding of the role of inflammation in healthy immune development.&#xD;
        Fecal samples will be collected from infants five times during the first 6 to 18 weeks of&#xD;
        life. Fecal CRP and calprotectin levels will be quantified to detect low-level inflammation&#xD;
        and enhance systemic results. Breastmilk will also be collected from lactating women at&#xD;
        corresponding collection times to assess breastfeeding's impact on immune development. In&#xD;
        addition to data collected on maternal BMI, maternal blood will be collected at 2 and 4&#xD;
        months postpartum to enhance investigations into maternal inflammatory status. Using existing&#xD;
        clinical partnerships, 30 maternal-infant dyads will be recruited during the first 6 weeks of&#xD;
        life and followed for 12 weeks. Dyads will include 15 breastfeeding infants, to be matched&#xD;
        with 15 infants receiving formula or other non-human-based milk products (i.e., plant based&#xD;
        formula). Dyads will be matched on infant sex and maternal BMI. A human milk sample will be&#xD;
        collected at 6, 8, 12, 16 and 18 weeks postpartum in connection with infant fecal samples&#xD;
        (Figure 1). Mothers can opt-in to collecting their own feces and saliva. Blood will be&#xD;
        obtained from infants during recurring pediatric wellness visits. Mothers will also be asked&#xD;
        to complete reoccurring surveys regarding their diet, perceived stress and anxiety, infant&#xD;
        diet, food introduction, and general infant behavior or level of fussiness. Maternal&#xD;
        demographics, including education level, household income, and food security, will be&#xD;
        collected upon enrollment. Electronic medical records will be accessed related to prenatal&#xD;
        care; maternal health and pre-existing conditions; birth records; and infant health status,&#xD;
        including growth and incidence of infection and use of antibiotics. The investigators will&#xD;
        measure the concentrations of inflammatory cytokines in fecal and blood samples from infants&#xD;
        and in milk and blood samples from their mothers. Flow cytometry will analyze infant and&#xD;
        maternal blood samples for circulating immune cell populations. When available, saliva&#xD;
        samples will be analyzed for cortisol concentration. Remaining infant and maternal fecal&#xD;
        samples will be retained for future microbiome investigations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Characterize the change in systemic inflammatory profile of healthy full-term infants</measure>
      <time_frame>Through study completion, an average of 12 weeks.</time_frame>
      <description>We will investigate infant inflammation across the first 4.5 months of life in serum and feces using biomarkers C-reactive protein, tumor necrosis factor-alpha, and other inflammatory interleukins and cytokines.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.</measure>
      <time_frame>Through study completion, an average of 12 weeks.</time_frame>
      <description>We will explore how maternal systemic inflammation may correlate with inflammatory markers within the breastmilk. We hypothesize that maternal systemic inflammation and health status will be correlated with increased inflammatory markers in breast milk if breastfeeding.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Characterize the change in blood mononuclear cell distribution of healthy full term infants.</measure>
      <time_frame>Through study completion, an average of 12 weeks.</time_frame>
      <description>We will assess this relationship by flow cytometry analysis of peripheral blood mononuclear cells at 2 and 4 months of age. We expect to capture biological variation in circulating immune cell populations in the developing infant. We hypothesize that infants with elevated inflammation would also have greater inflammatory immune cell proportions than their formula-fed counterparts.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Maternal Behavior</condition>
    <condition>Maternal Obesity</condition>
    <condition>Breast Milk Collection</condition>
    <condition>Infant Development</condition>
    <arm_group>
      <arm_group_label>Breastfeeding dyad</arm_group_label>
      <description>Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Formula feeding dyads</arm_group_label>
      <description>Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study,</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational</intervention_name>
      <description>This study is only observational in nature and will not include an intervention.</description>
      <arm_group_label>Breastfeeding dyad</arm_group_label>
      <arm_group_label>Formula feeding dyads</arm_group_label>
      <other_name>Observation only based on natural experiment of feeding groups</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Breastmilk samples will be collected when a woman is breastfeeding. Infant fecal samples will&#xD;
        be collected. Maternal and infant blood samples will be collected. Women can optionally&#xD;
        submit saliva and fecal samples.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Study population is postnatal women and their infant dyads.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mother at least 18 years of age&#xD;
  &#xD;
            -  Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of&#xD;
               age or younger&#xD;
  &#xD;
            -  Mother plans to continue to provide your infant breastmilk (by breastfeeding or by&#xD;
               pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to&#xD;
               continue to provide formula exclusively to infant for at least 18 weeks of life.&#xD;
  &#xD;
            -  Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples&#xD;
               for visits 2, 4, and 6.&#xD;
  &#xD;
            -  Mother willing to meet at (designated sample collection site) for visits 3 and 5 for&#xD;
               sample collection and visit activities.&#xD;
  &#xD;
            -  Mother willing to consent and comply with all aspects of the study protocol and&#xD;
               methods, save the optional activities and optional sample collections.&#xD;
  &#xD;
            -  Mother and infant are considered healthy by Principle Investigator.&#xD;
  &#xD;
            -  For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using&#xD;
               maternal BMI and infant sex.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mother or Infant have participated or are currently participating in an interventional&#xD;
               drug or device (non-observational) research study before.&#xD;
  &#xD;
            -  Mother reports that they, or the infant, have had an adverse effect during a venous&#xD;
               blood collection.&#xD;
  &#xD;
            -  Infant was born less than 36 weeks of gestation.&#xD;
  &#xD;
            -  Infant or mother have health conditions that increase the risk of study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>This project is focused on the effects of maternal inflammation and health status on the developing infant, including the role of breastfeeding and early feeding practices.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bethaney Fehrenkamp, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Idaho Clinical Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bethaney Fehrenkamp, PhD</last_name>
      <phone>208-885-1121</phone>
      <email>bethaney@uidaho.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Idaho</name>
        <address>
          <city>Moscow</city>
          <state>Idaho</state>
          <zip>83844</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Bethaney Fehrenkamp, PhD</last_name>
        <phone>208-885-1121</phone>
        <email>bethaney@uidaho.edu</email>
      </contact>
      <contact_backup>
        <phone_ext>Fehrenkamp</phone_ext>
        <email>bethaney@uidaho.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Bethaney Fehrenkamp, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Idaho</investigator_affiliation>
      <investigator_full_name>Bethaney Fehrenkamp</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Maternal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only deidentified data or samples will be shared with other researchers. The PI will ensure data confidentiality and deidentification of all data.</ipd_description>
    </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/NCT05986539
  org study id: 23-013
  nct id: NCT05986539
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Although breastfeeding has known protective effects, such as preventing childhood
        obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation
        rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese).
        Limited research exists on the impact of maternal inflammation, maternal body mass index
        (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on
        infant health outcomes, especially in healthy full-term infants.
  
        Objective: This study aims to expand understanding of the role of maternal inflammation on
        breastmilk composition and its effect on infant immune development. The investigators seek to
        investigate the relationship between maternal health status, breastmilk inflammatory
        concentrations, and balanced immune development in infants. Additionally, the investigators
        aim to explore the potential influence of early diet exposure, including maternal
        inflammatory status, on the risk of obesity and other inflammatory conditions.
  
        Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be
        recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will
        be analyzed. Flow cytometry will assess immune populations. Correlations between maternal
        systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be
        examined for breastfeeding mothers.
  
        Outcomes: The investigators hypothesize breastfed infants will display a more favorable
        anti-inflammatory profile. This study will identify factors influencing immune development
        and potential pathways linking early-life exposures to long-term health outcomes. Findings
        will inform strategies for promoting balanced immune development and elucidate the role of
        early diet exposure, including maternal inflammation, as a protective or risk factor for
        obesity and inflammatory conditions.
  The immune system of newborns is immature and undergoes rapid development during the first
        few months of life. Inflammation is a natural response to infection or tissue injury, but
        excessive or prolonged inflammation can be detrimental to immune development. Understanding
        the relationship between inflammation and immune development in healthy full-term infants is
        critical to developing effective interventions to promote healthy immune function in early
        life.
  
        This project will collect blood samples from healthy full-term infants at 2 and 4 months of
        age. The samples will be analyzed using flow cytometry to quantify the proportions and
        activation status of different immune cell populations, such as T, B, natural killer, and
        monocytes. The analysis will also include quantifying intracellular cytokines to assess the
        functional capacity of the immune cells. The samples will be analyzed using established
        methods to measure biomarkers of inflammation, such as CRP, TNF-alpha, and other inflammatory
        interleukins and cytokines. This project will expand upon biomarkers previously examined to
        aid in the overall understanding of the role of inflammation in healthy immune development.
        Fecal samples will be collected from infants five times during the first 6 to 18 weeks of
        life. Fecal CRP and calprotectin levels will be quantified to detect low-level inflammation
        and enhance systemic results. Breastmilk will also be collected from lactating women at
        corresponding collection times to assess breastfeeding's impact on immune development. In
        addition to data collected on maternal BMI, maternal blood will be collected at 2 and 4
        months postpartum to enhance investigations into maternal inflammatory status. Using existing
        clinical partnerships, 30 maternal-infant dyads will be recruited during the first 6 weeks of
        life and followed for 12 weeks. Dyads will include 15 breastfeeding infants, to be matched
        with 15 infants receiving formula or other non-human-based milk products (i.e., plant based
        formula). Dyads will be matched on infant sex and maternal BMI. A human milk sample will be
        collected at 6, 8, 12, 16 and 18 weeks postpartum in connection with infant fecal samples
        (Figure 1). Mothers can opt-in to collecting their own feces and saliva. Blood will be
        obtained from infants during recurring pediatric wellness visits. Mothers will also be asked
        to complete reoccurring surveys regarding their diet, perceived stress and anxiety, infant
        diet, food introduction, and general infant behavior or level of fussiness. Maternal
        demographics, including education level, household income, and food security, will be
        collected upon enrollment. Electronic medical records will be accessed related to prenatal
        care; maternal health and pre-existing conditions; birth records; and infant health status,
        including growth and incidence of infection and use of antibiotics. The investigators will
        measure the concentrations of inflammatory cytokines in fecal and blood samples from infants
        and in milk and blood samples from their mothers. Flow cytometry will analyze infant and
        maternal blood samples for circulating immune cell populations. When available, saliva
        samples will be analyzed for cortisol concentration. Remaining infant and maternal fecal
        samples will be retained for future microbiome investigations.
  observational model: Case-Control
  time perspective: Prospective
  measure: Characterize the change in systemic inflammatory profile of healthy full-term infants
  time frame: Through study completion, an average of 12 weeks.
  description: We will investigate infant inflammation across the first 4.5 months of life in serum and feces using biomarkers C-reactive protein, tumor necrosis factor-alpha, and other inflammatory interleukins and cytokines.
  measure: Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.
  time frame: Through study completion, an average of 12 weeks.
  description: We will explore how maternal systemic inflammation may correlate with inflammatory markers within the breastmilk. We hypothesize that maternal systemic inflammation and health status will be correlated with increased inflammatory markers in breast milk if breastfeeding.
  measure: Characterize the change in blood mononuclear cell distribution of healthy full term infants.
  time frame: Through study completion, an average of 12 weeks.
  description: We will assess this relationship by flow cytometry analysis of peripheral blood mononuclear cells at 2 and 4 months of age. We expect to capture biological variation in circulating immune cell populations in the developing infant. We hypothesize that infants with elevated inflammation would also have greater inflammatory immune cell proportions than their formula-fed counterparts.
  arm group label: Breastfeeding dyad
  description: Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study.
  arm group label: Formula feeding dyads
  description: Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study,
  intervention type: Other
  intervention name: Observational
  description: This study is only observational in nature and will not include an intervention.
  arm group label: Breastfeeding dyad
  arm group label: Formula feeding dyads
  other name: Observation only based on natural experiment of feeding groups
  Breastmilk samples will be collected when a woman is breastfeeding. Infant fecal samples will
        be collected. Maternal and infant blood samples will be collected. Women can optionally
        submit saliva and fecal samples.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: This project is focused on the effects of maternal inflammation and health status on the developing infant, including the role of breastfeeding and early feeding practices.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bethaney Fehrenkamp, PhD
  role: Principal Investigator
  affiliation: University of Idaho Clinical Assistant Professor
  last name: Bethaney Fehrenkamp, PhD
  phone: 208-885-1121
  email: bethaney@uidaho.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Idaho
  investigator full name: Bethaney Fehrenkamp
  investigator title: Clinical Assistant Professor
  mesh term: Obesity, Maternal
  sharing ipd: No
  ipd description: Only deidentified data or samples will be shared with other researchers. The PI will ensure data confidentiality and deidentification of all data.