<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/NCT03229863</url>
  </required_header>
  <id_info>
    <org_study_id>919505</org_study_id>
    <nct_id>NCT03229863</nct_id>
  </id_info>
  <brief_title>An Examination of Infants' Microbiome, Nutrition, and Development Study.</brief_title>
  <acronym>IMiND</acronym>
  <official_title>The Infant MiND Study: An Examination of Infants' Microbiome, Nutrition, and Development Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UC Davis Foods for Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mengniu Dairy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</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>
      This study is examining the relationship between infant nutrition, gut health, and&#xD;
      development. The fecal microbiota changes and develops, in large part due to the food that&#xD;
      infants eat. These changes are important for many aspects of development. This study is&#xD;
      designed to examine how the fecal microbiota changes when exclusively breastfed infants are&#xD;
      first introduced to solid food, and how changes of the fecal microbiota are related to other&#xD;
      aspects of development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine: 1) how the gut bacteria of exclusively breastfed&#xD;
      infants changes in response to ingesting solid foods; 2) how infant cognition develops in&#xD;
      response to ingesting solid foods; and 3) the relationship between infant gut bacteria and&#xD;
      infant cognition during the first year of life.&#xD;
&#xD;
      This study is designed to determine how specific complex carbohydrates in commonly used first&#xD;
      foods encourage the growth of different bacteria in the infant gut. The two foods used in&#xD;
      this study are commercially-available sweet potato (Plum Organics) and pear (Earth's Best).&#xD;
      These two foods have been chosen because they differ substantially from each other in their&#xD;
      carbohydrate composition. For example, sweet potato is mostly made up of starch which is&#xD;
      digestible and pear is made up of other types of sugars found in fruits and vegetables that&#xD;
      are not digestible and may have &quot;prebiotic&quot; effects (food for good bacteria in the gut).&#xD;
      Thus, the use of these two foods could provide a good contrast for comparing how gut bacteria&#xD;
      respond to different carbohydrate compositions during complementary feeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Anticipated">March 10, 2027</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This study is designed as a combined randomized, crossover interventional and observational trial. At the start of the study, infants will enter a 7-day lead-in period to establish gut microbiome and GI tolerability baselines. After the 7-day lead-in period, infants will be randomized into one of two feeding arms comprised of two commercially available baby foods: sweet potato (SP) (Plum Organics, Just Sweet Potato) and pears (P) (Earth's Best, First Pears). The first food, either sweet potato or pears, will be consumed for 7 days followed by a 4-day washout period of exclusive breast milk before initiating the alternate 7-day feeding arm of pears or sweet potato, respectively. The second feeding arm will be followed by an additional 4-day washout period of exclusive breast milk before the introduction of any other solid foods. Once the first month of the study is complete, infants will enter an observational phase for the remainder of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant fecal microbiota composition</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The difference in the relative abundance of the infant fecal microbiome at the order level (top 22 taxonomic orders with abundance expressed as both on log10 scale and a percent of total bacteria) between baseline and post-complementary food intake for each intervention arm (sweet potato vs. pear).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant fecal microbial diversity</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The difference in the infant fecal microbial diversity and microbial function between baseline and post-complementary food intake for each arm (sweet potato vs. pear)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Adverse Events and Treatments</measure>
    <time_frame>Baseline-days 180</time_frame>
    <description>Incidence of gastrointestinal symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability), illnesses, health care visits for sickness, high fevers, antibiotic and medication use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary composition</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant cognition</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant cognition measured at 6, 8 and 12 months of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant sleep</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant sleep, activity and vocalizations measured throughout the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal secretor status and infant fecal microbiota</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between maternal secretor status (via measurement of human milk oligosaccharides in breast milk) and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant secretor status and fecal microbiota</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between infant secretor status (via measurement of oligosaccharides in saliva) the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal and infant fecal microbiota</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The relationship between maternal and infant fecal microbiome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant fecal human milk oligosaccharide concentrations</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>Determine the relationship between infant weight and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human milk metabolomics</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal metabolomics</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gastrointestinal function</measure>
    <time_frame>Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180</time_frame>
    <description>Change in GI function as a means to monitor tolerability before, during and after introduction of complementary foods (through the measurement of fecal inflammatory mediators, GI barrier function markers and fecal LPS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycosidic linkages</measure>
    <time_frame>Change from baseline to day 29</time_frame>
    <description>Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Microbial Colonization</condition>
  <condition>Infant Development</condition>
  <arm_group>
    <arm_group_label>Sweet Potatos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pears</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sweet Potatos</intervention_name>
    <description>Plum Organics, Just Sweet Potato</description>
    <arm_group_label>Sweet Potatos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pears</intervention_name>
    <description>Earth's Best, First Pears</description>
    <arm_group_label>Pears</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, age 21 to 45 years who have delivered a healthy single infant by vaginal&#xD;
             delivery and their infants, age 4 to 7.5 months;&#xD;
&#xD;
          -  Infants who are developmentally ready for solids;&#xD;
&#xD;
          -  Generally healthy women and infants;&#xD;
&#xD;
          -  Mothers who plan to exclusively (without solids or infant formula) breastfeed (at the&#xD;
             breast or feed breast milk by bottle) their infants for at least 5 months of age and&#xD;
             plan to continue to breastfeed with solids and/or infant formula until 12 months of&#xD;
             age;&#xD;
&#xD;
          -  Mothers who are willing to either use their own breast pump, or hand-express, or use a&#xD;
             manual pump provided by the study to collect milk samples;&#xD;
&#xD;
          -  Mothers who are willing to refrain from feeding their infants infant formula,&#xD;
             non-study solid foods; probiotic or iron supplements (confounding variables of the&#xD;
             intestinal microbiome) before the end of the feeding intervention period;&#xD;
&#xD;
          -  Term infants born &gt;37 weeks gestation;&#xD;
&#xD;
          -  Mother-infant pairs who live within a 20-mile radius from University of California,&#xD;
             Davis campus in Davis, California (includes Woodland, Vacaville, Dixon and surrounding&#xD;
             areas) or within a 20-mile radius of the University of California, Davis Medical&#xD;
             Center (UCDMC) (2221 Stockton Blvd, Sacramento, CA 95817).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with any GI tract abnormalities;&#xD;
&#xD;
          -  Infants born by cesarean section;&#xD;
&#xD;
          -  Family history of immunodeficiency syndrome(s);&#xD;
&#xD;
          -  Multiple infants born to one mother at the same time (no twins, triplets, etc.);&#xD;
&#xD;
          -  Infants born with medical complications such as: respiratory distress syndrome, birth&#xD;
             defects, and infection;&#xD;
&#xD;
          -  Mothers diagnosed with any metabolic or endocrine, liver, kidney disease, any&#xD;
             autoimmune disease, cirrhosis, hepatitis C, HIV, AIDS, cancer, obesity (pre-pregnancy&#xD;
             BMI &gt;34.9), polycystic ovary syndrome (PCOS), celiac disease, Crohn's disease, heart&#xD;
             disease, hyper- or hypothyroidism, hyper- or hypotension (including pre-eclampsia),&#xD;
             type 1 or type 2 diabetes.&#xD;
&#xD;
          -  Mothers who smoked cigarettes less than one month before becoming pregnant, during&#xD;
             pregnancy, and currently or mothers who plan to initiate smoking during the study&#xD;
             duration;&#xD;
&#xD;
          -  Infants who have taken antibiotics within the past 4 weeks;&#xD;
&#xD;
          -  Infants who have taken iron supplements within the past 4 weeks;&#xD;
&#xD;
          -  Infants who have consumed infant formula in the past 4 weeks;&#xD;
&#xD;
          -  Infants who have consumed infant formula more than 10 days between birth and 4 weeks&#xD;
             prior to screening;&#xD;
&#xD;
          -  Infants who have consumed any solids;&#xD;
&#xD;
          -  Mothers who plan to feed infants solids before 5 months of age;&#xD;
&#xD;
          -  Mothers who plan to administer any probiotics to infants throughout the feeding&#xD;
             intervention period (first 18 days of the study);&#xD;
&#xD;
          -  Infants who have consumed probiotics containing Bifidobacterium within the past 4&#xD;
             weeks or other probiotics within the past 7 days;&#xD;
&#xD;
          -  Mothers who live in more than one location (should only live in one house to ensure&#xD;
             samples are correctly collected and stored);&#xD;
&#xD;
          -  Infants who have hypotonia,&#xD;
&#xD;
          -  Infants who have been diagnosed with any medical or nutritional condition that would&#xD;
             require iron supplementation.&#xD;
&#xD;
          -  Infants who on average pass less than one stool per week.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Smilowitz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Oakes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/an-examination-of-infants-microbiome-nutrition-and-development-study-123299/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
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    <citation>Diaz Heijtz R, Wang S, Anuar F, Qian Y, Bjorkholm B, Samuelsson A, Hibberd ML, Forssberg H, Pettersson S. Normal gut microbiota modulates brain development and behavior. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3047-52. doi: 10.1073/pnas.1010529108. Epub 2011 Jan 31.</citation>
    <PMID>21282636</PMID>
  </reference>
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  </reference>
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    <citation>Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20.</citation>
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  </reference>
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    <citation>Totten SM, Zivkovic AM, Wu S, Ngyuen U, Freeman SL, Ruhaak LR, Darboe MK, German JB, Prentice AM, Lebrilla CB. Comprehensive profiles of human milk oligosaccharides yield highly sensitive and specific markers for determining secretor status in lactating mothers. J Proteome Res. 2012 Dec 7;11(12):6124-33. doi: 10.1021/pr300769g. Epub 2012 Nov 19.</citation>
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  </reference>
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  </reference>
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  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>First foods</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</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/NCT03229863
org study id: 919505
nct id: NCT03229863
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is examining the relationship between infant nutrition, gut health, and
      development. The fecal microbiota changes and develops, in large part due to the food that
      infants eat. These changes are important for many aspects of development. This study is
      designed to examine how the fecal microbiota changes when exclusively breastfed infants are
      first introduced to solid food, and how changes of the fecal microbiota are related to other
      aspects of development.
The purpose of this study is to determine: 1) how the gut bacteria of exclusively breastfed
      infants changes in response to ingesting solid foods; 2) how infant cognition develops in
      response to ingesting solid foods; and 3) the relationship between infant gut bacteria and
      infant cognition during the first year of life.

      This study is designed to determine how specific complex carbohydrates in commonly used first
      foods encourage the growth of different bacteria in the infant gut. The two foods used in
      this study are commercially-available sweet potato (Plum Organics) and pear (Earth's Best).
      These two foods have been chosen because they differ substantially from each other in their
      carbohydrate composition. For example, sweet potato is mostly made up of starch which is
      digestible and pear is made up of other types of sugars found in fruits and vegetables that
      are not digestible and may have "prebiotic" effects (food for good bacteria in the gut).
      Thus, the use of these two foods could provide a good contrast for comparing how gut bacteria
      respond to different carbohydrate compositions during complementary feeding.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is designed as a combined randomized, crossover interventional and observational trial. At the start of the study, infants will enter a 7-day lead-in period to establish gut microbiome and GI tolerability baselines. After the 7-day lead-in period, infants will be randomized into one of two feeding arms comprised of two commercially available baby foods: sweet potato (SP) (Plum Organics, Just Sweet Potato) and pears (P) (Earth's Best, First Pears). The first food, either sweet potato or pears, will be consumed for 7 days followed by a 4-day washout period of exclusive breast milk before initiating the alternate 7-day feeding arm of pears or sweet potato, respectively. The second feeding arm will be followed by an additional 4-day washout period of exclusive breast milk before the introduction of any other solid foods. Once the first month of the study is complete, infants will enter an observational phase for the remainder of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Infant fecal microbiota composition
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The difference in the relative abundance of the infant fecal microbiome at the order level (top 22 taxonomic orders with abundance expressed as both on log10 scale and a percent of total bacteria) between baseline and post-complementary food intake for each intervention arm (sweet potato vs. pear).
measure: Infant fecal microbial diversity
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The difference in the infant fecal microbial diversity and microbial function between baseline and post-complementary food intake for each arm (sweet potato vs. pear)
measure: Incidence of Adverse Events and Treatments
time frame: Baseline-days 180
description: Incidence of gastrointestinal symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability), illnesses, health care visits for sickness, high fevers, antibiotic and medication use.
measure: Dietary composition
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.
measure: Infant cognition
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant cognition measured at 6, 8 and 12 months of age
measure: Infant sleep
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant sleep, activity and vocalizations measured throughout the study period.
measure: Maternal secretor status and infant fecal microbiota
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between maternal secretor status (via measurement of human milk oligosaccharides in breast milk) and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
measure: Infant secretor status and fecal microbiota
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between infant secretor status (via measurement of oligosaccharides in saliva) the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
measure: Maternal and infant fecal microbiota
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The relationship between maternal and infant fecal microbiome.
measure: Infant fecal human milk oligosaccharide concentrations
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.
measure: Infant weight
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: Determine the relationship between infant weight and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods
measure: Human milk metabolomics
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.
measure: Fecal metabolomics
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.
measure: Infant gastrointestinal function
time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
description: Change in GI function as a means to monitor tolerability before, during and after introduction of complementary foods (through the measurement of fecal inflammatory mediators, GI barrier function markers and fecal LPS).
measure: Glycosidic linkages
time frame: Change from baseline to day 29
description: Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.
arm group label: Sweet Potatos
arm group type: Experimental
description: Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row.
arm group label: Pears
arm group type: Experimental
description: Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row.
intervention type: Other
intervention name: Sweet Potatos
description: Plum Organics, Just Sweet Potato
arm group label: Sweet Potatos
intervention type: Other
intervention name: Pears
description: Earth's Best, First Pears
arm group label: Pears
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Smilowitz, PhD
role: Principal Investigator
affiliation: University of California, Davis
last name: Lisa Oakes, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
url: https://studypages.com/s/an-examination-of-infants-microbiome-nutrition-and-development-study-123299/
description: Learn more or sign up for the study here!
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PMID: 24956966
citation: Totten SM, Zivkovic AM, Wu S, Ngyuen U, Freeman SL, Ruhaak LR, Darboe MK, German JB, Prentice AM, Lebrilla CB. Comprehensive profiles of human milk oligosaccharides yield highly sensitive and specific markers for determining secretor status in lactating mothers. J Proteome Res. 2012 Dec 7;11(12):6124-33. doi: 10.1021/pr300769g. Epub 2012 Nov 19.
PMID: 23140396
citation: Tao N, DePeters EJ, Freeman S, German JB, Grimm R, Lebrilla CB. Bovine milk glycome. J Dairy Sci. 2008 Oct;91(10):3768-78. doi: 10.3168/jds.2008-1305.
PMID: 18832198
citation: Tao N, DePeters EJ, German JB, Grimm R, Lebrilla CB. Variations in bovine milk oligosaccharides during early and middle lactation stages analyzed by high-performance liquid chromatography-chip/mass spectrometry. J Dairy Sci. 2009 Jul;92(7):2991-3001. doi: 10.3168/jds.2008-1642.
PMID: 19528576
citation: Vatanen T, Kostic AD, d'Hennezel E, Siljander H, Franzosa EA, Yassour M, Kolde R, Vlamakis H, Arthur TD, Hamalainen AM, Peet A, Tillmann V, Uibo R, Mokurov S, Dorshakova N, Ilonen J, Virtanen SM, Szabo SJ, Porter JA, Lahdesmaki H, Huttenhower C, Gevers D, Cullen TW, Knip M; DIABIMMUNE Study Group; Xavier RJ. Variation in Microbiome LPS Immunogenicity Contributes to Autoimmunity in Humans. Cell. 2016 May 5;165(4):842-53. doi: 10.1016/j.cell.2016.04.007. Epub 2016 Apr 28. Erratum In: Cell. 2016 Jun 2;165(6):1551.
PMID: 27133167
citation: Rotmistrovsky, K. and R. Agarwala, BMTagger: Best Match Tagger for removing human reads from metagenomics datasets. 2011.
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PMID: 21408061
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PMID: 25926546
citation: Kleinman RE. American Academy of Pediatrics recommendations for complementary feeding. Pediatrics. 2000 Nov;106(5):1274. No abstract available.
PMID: 11061819
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections