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/NCT06002438</url>
    </required_header>
    <id_info>
      <org_study_id>202306090</org_study_id>
      <nct_id>NCT06002438</nct_id>
    </id_info>
    <brief_title>Eggs for Gut Health</brief_title>
    <official_title>Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Project Peanut Butter</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Thrasher Research Fund</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ministry of Health and Sanitation, Sierra Leone</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</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>
        The goal of this clinical trial is to test egg powder supplementation in children with&#xD;
        moderate acute malnutrition in Sierra Leone. The main question it aims to answer is:&#xD;
  &#xD;
        - Will provision of 15g of whole egg powder per day during and after treatment for moderate&#xD;
        acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear&#xD;
        growth among 6-30 month old Sierra Leonean children compared with daily corn powder&#xD;
        supplementation?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Undernutrition in children manifests as wasting, stunting, or both. While wasting is&#xD;
        generally responsive to high-quality nutritional interventions, stunting is less so. Affected&#xD;
        children are at increased risk of acute and chronic illnesses, have reduced neurocognitive&#xD;
        development, lower academic achievement, reduced adult earning potential, and shortened&#xD;
        lifespans. Given that stunting affects over 140 million children at any one time, the costs&#xD;
        incurred are deep and broad, particularly among children in sub-Saharan Africa, where nearly&#xD;
        half of the world's population growth is expected to occur over the next 30 years. Part of&#xD;
        the challenge of treating stunting has been attributed to environmental enteric dysfunction&#xD;
        (EED), an acquired small intestine disorder characterized by chronic inflammation, villus&#xD;
        blunting, and impaired nutrient absorption. EED is prevalent in the same populations plagued&#xD;
        by stunting, develops concurrently with loss in linear growth, and has explained upwards of&#xD;
        43% of observed growth faltering. EED has recently also been found in over 75% of children&#xD;
        with moderate acute malnutrition (MAM, moderate wasting) in Sierra Leone, a population with&#xD;
        high rates of deterioration to severe acute malnutrition and death, 20%. EED is a plausible&#xD;
        cause for this treatment resistance, and for the high rates of recurrence seen in these&#xD;
        children. There is an urgent need to increase understanding of the concurrence of stunting,&#xD;
        EED, and wasting, and to test interventions targeted to their pathological underpinnings.&#xD;
        Dietary egg can play a critical role in the fight against malnutrition by providing abundant&#xD;
        high-quality protein and nutrients essential for physical and cognitive recovery. One egg/day&#xD;
        has been shown to reduce stunting in several contexts. Recent evidence has shown that&#xD;
        short-term egg/bovine colostrum supplement given to 9-12-month-old Malawian children improved&#xD;
        linear growth and intestinal permeability in children with severe EED. It is possible that&#xD;
        prolonged supplementation with egg in a high-risk population in rural Sierra Leone could&#xD;
        improve acute and long-term health trajectories for children and put eggs on the map for food&#xD;
        aid. This will be a randomized, investigator-blinded, controlled clinical trial testing&#xD;
        whether daily supplementation with 15g whole egg powder during and for 18 weeks after&#xD;
        treatment for moderate acute malnutrition might reduce intestinal permeability and improve&#xD;
        linear growth, among other outcomes, when compared with control corn powder. Children with&#xD;
        relatively higher risk MAM will be enrolled (MUAC &lt; 12.5 cm AND MUACz &lt; -2), treated with&#xD;
        Supercereal Plus for up to 6 weeks, and undergo urine and stool collections at 6, 12, and 24&#xD;
        weeks. Urine collections will be for assessment of lactulose permeability and will involve&#xD;
        participant consumption of a known amount of lactulose and collection of all urine over at&#xD;
        least 4 hours thereafter. Stool collections will be for fecal host mRNA transcripts and&#xD;
        selected proteins. Participants will also receive intermittent malaria chemoprophylaxis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>The intervention and control powders will be packaged such that investigators and outcomes assessors will not know their identity. Participants and care providers are likely to be able to distinguish them, however.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percent lactulose excretion</measure>
      <time_frame>Collected 12 and 24 weeks after enrollment</time_frame>
      <description>% lactulose excretion in urine over &gt;=4 hours after lactulose consumption</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in length-for-age z-score</measure>
      <time_frame>Measured 12 and 24 weeks after enrollment</time_frame>
      <description>Difference in length-for-age z-score between enrollment and weeks 12 and 24. Covariate will be baseline LAZ.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>% Lactulose excretion &gt;= 0.2 and &gt;=0.45</measure>
      <time_frame>Collected 6, 12, and 24 weeks after enrollment</time_frame>
      <description>Proportion with moderately and severely abnormal small intestinal permeability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of length gain</measure>
      <time_frame>Across 24 week follow-up period</time_frame>
      <description>mm/week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LAZ &lt; -2</measure>
      <time_frame>Measured 6, 12, 18, and 24 weeks after enrollment</time_frame>
      <description>Proportion stunted</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal host mRNA transcripts</measure>
      <time_frame>Collected 12 and 24 weeks after enrollment</time_frame>
      <description>CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal host proteins MPO, AAT, NEO</measure>
      <time_frame>Collected 12 and 24 weeks after enrollment</time_frame>
      <description>Myeloperoxidase, alpha-1 antitrypsin, neopterin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of weight gain</measure>
      <time_frame>Enrollment to week 6, and across 24 week follow-up period</time_frame>
      <description>g/kg/d</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>% Lactulose excretion</measure>
      <time_frame>6 weeks after enrollment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Deterioration to severe acute malnutrition or death</measure>
      <time_frame>Time-to-event across follow-up period</time_frame>
      <description>Mid-upper arm circumference &lt; 11.5 cm or nutritional edema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence of MAM</measure>
      <time_frame>Time-to-event across follow-up period</time_frame>
      <description>MUAC &lt; 12.5 cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sustained recovery</measure>
      <time_frame>Weeks 12, 18, 24</time_frame>
      <description>Mid-upper arm circumference &gt;= 12.5 cm without nutritional edema</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Moderate Acute Malnutrition</condition>
    <condition>Stunting</condition>
    <condition>Environmental Enteric Dysfunction</condition>
    <condition>Severe Acute Malnutrition</condition>
    <arm_group>
      <arm_group_label>Egg powder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>15g egg powder per day for 24 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Corn powder</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>15g corn powder per day for 24 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Whole egg powder</intervention_name>
      <description>15g daily dose for 24 weeks</description>
      <arm_group_label>Egg powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Corn powder</intervention_name>
      <description>15g daily dose for 24 weeks</description>
      <arm_group_label>Corn powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Supercereal Plus</intervention_name>
      <description>75 kcal/kg/day supplementary food to be provided for treatment of MAM for up to 6 weeks.</description>
      <arm_group_label>Corn powder</arm_group_label>
      <arm_group_label>Egg powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Micronutrient sprinkles</intervention_name>
      <description>To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.</description>
      <arm_group_label>Corn powder</arm_group_label>
      <arm_group_label>Egg powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sulfadoxine pyrimethamine</intervention_name>
      <description>Infants &lt; 12 months of age: 250/12.5mg SP at enrollment, week 6, week 12, week 18.&#xD;
  Infants &gt;= 12 months of age: 500/25mg SP at enrollment, week 6, week 12, week 18.</description>
      <arm_group_label>Corn powder</arm_group_label>
      <arm_group_label>Egg powder</arm_group_label>
      <other_name>SP</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Amodiaquine</intervention_name>
      <description>Infants &lt; 12 months of age: 75mg AQ for 3 days at enrollment, week 6, week 12, week 18.&#xD;
  Infants &gt;= 12 months of age: 150mg AQ for 3 days at enrollment, week 6, week 12, week 18.</description>
      <arm_group_label>Corn powder</arm_group_label>
      <arm_group_label>Egg powder</arm_group_label>
      <other_name>AQ</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 6 months of age and less than 30 months of age&#xD;
  &#xD;
            -  Mid-upper arm circumference &lt; 12. 5 cm&#xD;
  &#xD;
            -  Mid-upper arm circumference-for-age z-score &lt; -2&#xD;
  &#xD;
            -  Provision of signed (or thumb-printed) and dated informed consent form&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study, including no plan to move from the catchment area of a&#xD;
               participating clinic&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Nutritional edema&#xD;
  &#xD;
            -  Simultaneous involvement in another research trial or supplementary feeding program&#xD;
  &#xD;
            -  Chronic debilitating illness&#xD;
  &#xD;
            -  Allergy to egg&#xD;
  &#xD;
            -  Receipt of treatment for acute malnutrition within 1 month prior to screening&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>30 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark J Manary, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mark J Manary, MD</last_name>
      <phone>+1 314-454-2341</phone>
      <email>manarymj@wustl.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Malnutrition</mesh_term>
      <mesh_term>Severe Acute Malnutrition</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Micronutrients</mesh_term>
      <mesh_term>Trace Elements</mesh_term>
      <mesh_term>Pyrimethamine</mesh_term>
      <mesh_term>Sulfadoxine</mesh_term>
      <mesh_term>Fanasil, pyrimethamine drug combination</mesh_term>
      <mesh_term>Amodiaquine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Within 12 months of primary publication</ipd_time_frame>
    </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/NCT06002438
  org study id: 202306090
  nct id: NCT06002438
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test egg powder supplementation in children with
        moderate acute malnutrition in Sierra Leone. The main question it aims to answer is:
  
        - Will provision of 15g of whole egg powder per day during and after treatment for moderate
        acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear
        growth among 6-30 month old Sierra Leonean children compared with daily corn powder
        supplementation?
  Undernutrition in children manifests as wasting, stunting, or both. While wasting is
        generally responsive to high-quality nutritional interventions, stunting is less so. Affected
        children are at increased risk of acute and chronic illnesses, have reduced neurocognitive
        development, lower academic achievement, reduced adult earning potential, and shortened
        lifespans. Given that stunting affects over 140 million children at any one time, the costs
        incurred are deep and broad, particularly among children in sub-Saharan Africa, where nearly
        half of the world's population growth is expected to occur over the next 30 years. Part of
        the challenge of treating stunting has been attributed to environmental enteric dysfunction
        (EED), an acquired small intestine disorder characterized by chronic inflammation, villus
        blunting, and impaired nutrient absorption. EED is prevalent in the same populations plagued
        by stunting, develops concurrently with loss in linear growth, and has explained upwards of
        43% of observed growth faltering. EED has recently also been found in over 75% of children
        with moderate acute malnutrition (MAM, moderate wasting) in Sierra Leone, a population with
        high rates of deterioration to severe acute malnutrition and death, 20%. EED is a plausible
        cause for this treatment resistance, and for the high rates of recurrence seen in these
        children. There is an urgent need to increase understanding of the concurrence of stunting,
        EED, and wasting, and to test interventions targeted to their pathological underpinnings.
        Dietary egg can play a critical role in the fight against malnutrition by providing abundant
        high-quality protein and nutrients essential for physical and cognitive recovery. One egg/day
        has been shown to reduce stunting in several contexts. Recent evidence has shown that
        short-term egg/bovine colostrum supplement given to 9-12-month-old Malawian children improved
        linear growth and intestinal permeability in children with severe EED. It is possible that
        prolonged supplementation with egg in a high-risk population in rural Sierra Leone could
        improve acute and long-term health trajectories for children and put eggs on the map for food
        aid. This will be a randomized, investigator-blinded, controlled clinical trial testing
        whether daily supplementation with 15g whole egg powder during and for 18 weeks after
        treatment for moderate acute malnutrition might reduce intestinal permeability and improve
        linear growth, among other outcomes, when compared with control corn powder. Children with
        relatively higher risk MAM will be enrolled (MUAC < 12.5 cm AND MUACz < -2), treated with
        Supercereal Plus for up to 6 weeks, and undergo urine and stool collections at 6, 12, and 24
        weeks. Urine collections will be for assessment of lactulose permeability and will involve
        participant consumption of a known amount of lactulose and collection of all urine over at
        least 4 hours thereafter. Stool collections will be for fecal host mRNA transcripts and
        selected proteins. Participants will also receive intermittent malaria chemoprophylaxis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: The intervention and control powders will be packaged such that investigators and outcomes assessors will not know their identity. Participants and care providers are likely to be able to distinguish them, however.
  measure: Percent lactulose excretion
  time frame: Collected 12 and 24 weeks after enrollment
  description: % lactulose excretion in urine over >=4 hours after lactulose consumption
  measure: Change in length-for-age z-score
  time frame: Measured 12 and 24 weeks after enrollment
  description: Difference in length-for-age z-score between enrollment and weeks 12 and 24. Covariate will be baseline LAZ.
  measure: % Lactulose excretion >= 0.2 and >=0.45
  time frame: Collected 6, 12, and 24 weeks after enrollment
  description: Proportion with moderately and severely abnormal small intestinal permeability
  measure: Rate of length gain
  time frame: Across 24 week follow-up period
  description: mm/week
  measure: LAZ < -2
  time frame: Measured 6, 12, 18, and 24 weeks after enrollment
  description: Proportion stunted
  measure: Fecal host mRNA transcripts
  time frame: Collected 12 and 24 weeks after enrollment
  description: CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
  measure: Fecal host proteins MPO, AAT, NEO
  time frame: Collected 12 and 24 weeks after enrollment
  description: Myeloperoxidase, alpha-1 antitrypsin, neopterin
  measure: Rate of weight gain
  time frame: Enrollment to week 6, and across 24 week follow-up period
  description: g/kg/d
  measure: % Lactulose excretion
  time frame: 6 weeks after enrollment
  measure: Deterioration to severe acute malnutrition or death
  time frame: Time-to-event across follow-up period
  description: Mid-upper arm circumference < 11.5 cm or nutritional edema
  measure: Recurrence of MAM
  time frame: Time-to-event across follow-up period
  description: MUAC < 12.5 cm
  measure: Sustained recovery
  time frame: Weeks 12, 18, 24
  description: Mid-upper arm circumference >= 12.5 cm without nutritional edema
  arm group label: Egg powder
  arm group type: Experimental
  description: 15g egg powder per day for 24 weeks
  arm group label: Corn powder
  arm group type: Active Comparator
  description: 15g corn powder per day for 24 weeks
  intervention type: Dietary Supplement
  intervention name: Whole egg powder
  description: 15g daily dose for 24 weeks
  arm group label: Egg powder
  intervention type: Dietary Supplement
  intervention name: Corn powder
  description: 15g daily dose for 24 weeks
  arm group label: Corn powder
  intervention type: Dietary Supplement
  intervention name: Supercereal Plus
  description: 75 kcal/kg/day supplementary food to be provided for treatment of MAM for up to 6 weeks.
  arm group label: Corn powder
  arm group label: Egg powder
  intervention type: Dietary Supplement
  intervention name: Micronutrient sprinkles
  description: To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.
  arm group label: Corn powder
  arm group label: Egg powder
  intervention type: Drug
  intervention name: Sulfadoxine pyrimethamine
  description: Infants < 12 months of age: 250/12.5mg SP at enrollment, week 6, week 12, week 18.
  Infants >= 12 months of age: 500/25mg SP at enrollment, week 6, week 12, week 18.
  arm group label: Corn powder
  arm group label: Egg powder
  other name: SP
  intervention type: Drug
  intervention name: Amodiaquine
  description: Infants < 12 months of age: 75mg AQ for 3 days at enrollment, week 6, week 12, week 18.
  Infants >= 12 months of age: 150mg AQ for 3 days at enrollment, week 6, week 12, week 18.
  arm group label: Corn powder
  arm group label: Egg powder
  other name: AQ
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 30 Months
  healthy volunteers: No
  last name: Mark J Manary, MD
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Mark J Manary, MD
  phone: +1 314-454-2341
  email: manarymj@wustl.edu
  responsible party type: Sponsor
  mesh term: Malnutrition
  mesh term: Severe Acute Malnutrition
  mesh term: Micronutrients
  mesh term: Trace Elements
  mesh term: Pyrimethamine
  mesh term: Sulfadoxine
  mesh term: Fanasil, pyrimethamine drug combination
  mesh term: Amodiaquine
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Within 12 months of primary publication