<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/NCT03801317</url>
  </required_header>
  <id_info>
    <org_study_id>201808199</org_study_id>
    <nct_id>NCT03801317</nct_id>
  </id_info>
  <brief_title>The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children</brief_title>
  <official_title>The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children</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>Kamuzu University of Health Sciences</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 trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine&#xD;
      colostrum or a control flour along with a multiple micronutrient powder to the diets of&#xD;
      healthy Malawian children 9 months of age. This supplement provides additional essential&#xD;
      amino acids, choline and immunoactive colostrum. Children will be receive either the&#xD;
      supplement or control for 12 weeks. Children will have regular follow-up where anthropometry&#xD;
      is measured. At enrollment and after 12 weeks, stool will be collected and a urinary&#xD;
      lactulose permeability test conducted. Children will be measured at enrollment and at weeks&#xD;
      2, 4, 8, 12, 20, 32 after enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intestinal permeability</measure>
    <time_frame>12 weeks</time_frame>
    <description>The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Linear growth</measure>
    <time_frame>12 weeks and 32 weeks</time_frame>
    <description>Change in length expressed as anthropometric z-score from enrollment to end point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of diarrhea</measure>
    <time_frame>12 weeks</time_frame>
    <description>Caregiver report of number of days they child has diarrhea over the course of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of the bovine colostrum/ egg</measure>
    <time_frame>12 weeks</time_frame>
    <description>Caregiver report of number of days they child has adverse effects over the course of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>16S configuration of fecal microbiota</measure>
    <time_frame>12 weeks</time_frame>
    <description>Looking at the 16S configuration in stool samples collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stunting</measure>
    <time_frame>12 and 32 weeks</time_frame>
    <description>Categorization of length-for-age z-scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Environmental enteric dysfunction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Categorization of lactulose permeability measurements</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Stunting</condition>
  <condition>Environmental Enteric Dysfunction</condition>
  <arm_group>
    <arm_group_label>BC/ egg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4.3 grams egg powder + 5.7 grams bovine colostrum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15 grams corn-soya blend</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BC/ egg</intervention_name>
    <description>4.3 egg powder + 5.7 g bovine colostrum</description>
    <arm_group_label>BC/ egg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>15 grams corn-soya blend</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>multiple micronutrient</intervention_name>
    <description>multiple micronutrient sprinkle powder</description>
    <arm_group_label>BC/ egg</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Children at 9-10 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malnutrition&#xD;
&#xD;
          -  congenital abnormalities&#xD;
&#xD;
          -  chronic diseases such as heart disease, cerebral palsy, or HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>10 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Project Peanut Butter, Malawi</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <reference>
    <citation>Owino V, Ahmed T, Freemark M, Kelly P, Loy A, Manary M, Loechl C. Environmental Enteric Dysfunction and Growth Failure/Stunting in Global Child Health. Pediatrics. 2016 Dec;138(6):e20160641. doi: 10.1542/peds.2016-0641. Epub 2016 Nov 4.</citation>
    <PMID>27940670</PMID>
  </reference>
  <reference>
    <citation>Prendergast AJ, Humphrey JH. The stunting syndrome in developing countries. Paediatr Int Child Health. 2014 Nov;34(4):250-65. doi: 10.1179/2046905514Y.0000000158. Epub 2014 Oct 13.</citation>
    <PMID>25310000</PMID>
  </reference>
  <reference>
    <citation>McKay S, Gaudier E, Campbell DI, Prentice AM, Albers R. Environmental enteropathy: new targets for nutritional interventions. Int Health. 2010 Sep;2(3):172-80. doi: 10.1016/j.inhe.2010.07.006.</citation>
    <PMID>24037697</PMID>
  </reference>
  <reference>
    <citation>Ordiz MI, Stephenson K, Agapova S, Wylie KM, Maleta K, Martin J, Trehan I, Tarr PI, Manary MJ. Environmental Enteric Dysfunction and the Fecal Microbiota in Malawian Children. Am J Trop Med Hyg. 2017 Feb 8;96(2):473-476. doi: 10.4269/ajtmh.16-0617. Epub 2016 Dec 12.</citation>
    <PMID>27956653</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Trehan I, Li X, Moaddel R, Ordiz MI, Maleta KM, Kraemer K, Shardell M, Ferrucci L, Manary M. Environmental Enteric Dysfunction is Associated with Carnitine Deficiency and Altered Fatty Acid Oxidation. EBioMedicine. 2017 Mar;17:57-66. doi: 10.1016/j.ebiom.2017.01.026. Epub 2017 Jan 18.</citation>
    <PMID>28122695</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Khadeer M, Ordiz MI, Ferrucci L, Manary MJ. Environmental Enteric Dysfunction Is Associated With Altered Bile Acid Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):536-540. doi: 10.1097/MPG.0000000000001313.</citation>
    <PMID>27322559</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Shardell M, Sakr Ashour FA, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Kraemer K, Khadeer MA, Ferrucci L, Manary MJ. Child Stunting is Associated with Low Circulating Essential Amino Acids. EBioMedicine. 2016 Apr;6:246-252. doi: 10.1016/j.ebiom.2016.02.030. Epub 2016 Feb 19.</citation>
    <PMID>27211567</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Zhang P, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Ferrucci L, Manary MJ. The association of serum choline with linear growth failure in young children from rural Malawi. Am J Clin Nutr. 2016 Jul;104(1):191-7. doi: 10.3945/ajcn.115.129684. Epub 2016 Jun 8.</citation>
    <PMID>27281303</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Shardell M, Trehan I, Moaddel R, Maleta KM, Ordiz MI, Kraemer K, Khadeer M, Ferrucci L, Manary MJ. Metabolic alterations in children with environmental enteric dysfunction. Sci Rep. 2016 Jun 13;6:28009. doi: 10.1038/srep28009.</citation>
    <PMID>27294788</PMID>
  </reference>
  <reference>
    <citation>Semba RD, Trehan I, Gonzalez-Freire M, Kraemer K, Moaddel R, Ordiz MI, Ferrucci L, Manary MJ. Perspective: The Potential Role of Essential Amino Acids and the Mechanistic Target of Rapamycin Complex 1 (mTORC1) Pathway in the Pathogenesis of Child Stunting. Adv Nutr. 2016 Sep 15;7(5):853-65. doi: 10.3945/an.116.013276. Print 2016 Sep.</citation>
    <PMID>27633102</PMID>
  </reference>
  <reference>
    <citation>Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7.</citation>
    <PMID>24807641</PMID>
  </reference>
  <reference>
    <citation>Saad K, Abo-Elela MGM, El-Baseer KAA, Ahmed AE, Ahmad FA, Tawfeek MSK, El-Houfey AA, Aboul Khair MD, Abdel-Salam AM, Abo-Elgheit A, Qubaisy H, Ali AM, Abdel-Mawgoud E. Effects of bovine colostrum on recurrent respiratory tract infections and diarrhea in children. Medicine (Baltimore). 2016 Sep;95(37):e4560. doi: 10.1097/MD.0000000000004560.</citation>
    <PMID>27631207</PMID>
  </reference>
  <reference>
    <citation>Halasa M, Maciejewska D, Baskiewicz-Halasa M, Machalinski B, Safranow K, Stachowska E. Oral Supplementation with Bovine Colostrum Decreases Intestinal Permeability and Stool Concentrations of Zonulin in Athletes. Nutrients. 2017 Apr 8;9(4):370. doi: 10.3390/nu9040370.</citation>
    <PMID>28397754</PMID>
  </reference>
  <reference>
    <citation>Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Cantrell JA, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Prophylactic Efficacy of Hyperimmune Bovine Colostral Antiadhesin Antibodies Against Enterotoxigenic Escherichia coli Diarrhea: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial. J Infect Dis. 2017 Jul 1;216(1):7-13. doi: 10.1093/infdis/jix144.</citation>
    <PMID>28541500</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</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>Growth Disorders</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801317
org study id: 201808199
nct id: NCT03801317
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine
      colostrum or a control flour along with a multiple micronutrient powder to the diets of
      healthy Malawian children 9 months of age. This supplement provides additional essential
      amino acids, choline and immunoactive colostrum. Children will be receive either the
      supplement or control for 12 weeks. Children will have regular follow-up where anthropometry
      is measured. At enrollment and after 12 weeks, stool will be collected and a urinary
      lactulose permeability test conducted. Children will be measured at enrollment and at weeks
      2, 4, 8, 12, 20, 32 after enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Intestinal permeability
time frame: 12 weeks
description: The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
measure: Linear growth
time frame: 12 weeks and 32 weeks
description: Change in length expressed as anthropometric z-score from enrollment to end point
measure: Incidence of diarrhea
time frame: 12 weeks
description: Caregiver report of number of days they child has diarrhea over the course of the study
measure: Adverse effects of the bovine colostrum/ egg
time frame: 12 weeks
description: Caregiver report of number of days they child has adverse effects over the course of the study
measure: 16S configuration of fecal microbiota
time frame: 12 weeks
description: Looking at the 16S configuration in stool samples collected
measure: Stunting
time frame: 12 and 32 weeks
description: Categorization of length-for-age z-scores
measure: Environmental enteric dysfunction
time frame: 12 weeks
description: Categorization of lactulose permeability measurements
arm group label: BC/ egg
arm group type: Experimental
description: 4.3 grams egg powder + 5.7 grams bovine colostrum
arm group label: Control
arm group type: Placebo Comparator
description: 15 grams corn-soya blend
intervention type: Dietary Supplement
intervention name: BC/ egg
description: 4.3 egg powder + 5.7 g bovine colostrum
arm group label: BC/ egg
intervention type: Dietary Supplement
intervention name: Control
description: 15 grams corn-soya blend
arm group label: Control
intervention type: Dietary Supplement
intervention name: multiple micronutrient
description: multiple micronutrient sprinkle powder
arm group label: BC/ egg
arm group label: Control
criteria: 
gender: All
minimum age: 9 Months
maximum age: 10 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Malawi
citation: Owino V, Ahmed T, Freemark M, Kelly P, Loy A, Manary M, Loechl C. Environmental Enteric Dysfunction and Growth Failure/Stunting in Global Child Health. Pediatrics. 2016 Dec;138(6):e20160641. doi: 10.1542/peds.2016-0641. Epub 2016 Nov 4.
PMID: 27940670
citation: Prendergast AJ, Humphrey JH. The stunting syndrome in developing countries. Paediatr Int Child Health. 2014 Nov;34(4):250-65. doi: 10.1179/2046905514Y.0000000158. Epub 2014 Oct 13.
PMID: 25310000
citation: McKay S, Gaudier E, Campbell DI, Prentice AM, Albers R. Environmental enteropathy: new targets for nutritional interventions. Int Health. 2010 Sep;2(3):172-80. doi: 10.1016/j.inhe.2010.07.006.
PMID: 24037697
citation: Ordiz MI, Stephenson K, Agapova S, Wylie KM, Maleta K, Martin J, Trehan I, Tarr PI, Manary MJ. Environmental Enteric Dysfunction and the Fecal Microbiota in Malawian Children. Am J Trop Med Hyg. 2017 Feb 8;96(2):473-476. doi: 10.4269/ajtmh.16-0617. Epub 2016 Dec 12.
PMID: 27956653
citation: Semba RD, Trehan I, Li X, Moaddel R, Ordiz MI, Maleta KM, Kraemer K, Shardell M, Ferrucci L, Manary M. Environmental Enteric Dysfunction is Associated with Carnitine Deficiency and Altered Fatty Acid Oxidation. EBioMedicine. 2017 Mar;17:57-66. doi: 10.1016/j.ebiom.2017.01.026. Epub 2017 Jan 18.
PMID: 28122695
citation: Semba RD, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Khadeer M, Ordiz MI, Ferrucci L, Manary MJ. Environmental Enteric Dysfunction Is Associated With Altered Bile Acid Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):536-540. doi: 10.1097/MPG.0000000000001313.
PMID: 27322559
citation: Semba RD, Shardell M, Sakr Ashour FA, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Kraemer K, Khadeer MA, Ferrucci L, Manary MJ. Child Stunting is Associated with Low Circulating Essential Amino Acids. EBioMedicine. 2016 Apr;6:246-252. doi: 10.1016/j.ebiom.2016.02.030. Epub 2016 Feb 19.
PMID: 27211567
citation: Semba RD, Zhang P, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Ferrucci L, Manary MJ. The association of serum choline with linear growth failure in young children from rural Malawi. Am J Clin Nutr. 2016 Jul;104(1):191-7. doi: 10.3945/ajcn.115.129684. Epub 2016 Jun 8.
PMID: 27281303
citation: Semba RD, Shardell M, Trehan I, Moaddel R, Maleta KM, Ordiz MI, Kraemer K, Khadeer M, Ferrucci L, Manary MJ. Metabolic alterations in children with environmental enteric dysfunction. Sci Rep. 2016 Jun 13;6:28009. doi: 10.1038/srep28009.
PMID: 27294788
citation: Semba RD, Trehan I, Gonzalez-Freire M, Kraemer K, Moaddel R, Ordiz MI, Ferrucci L, Manary MJ. Perspective: The Potential Role of Essential Amino Acids and the Mechanistic Target of Rapamycin Complex 1 (mTORC1) Pathway in the Pathogenesis of Child Stunting. Adv Nutr. 2016 Sep 15;7(5):853-65. doi: 10.3945/an.116.013276. Print 2016 Sep.
PMID: 27633102
citation: Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7.
PMID: 24807641
citation: Saad K, Abo-Elela MGM, El-Baseer KAA, Ahmed AE, Ahmad FA, Tawfeek MSK, El-Houfey AA, Aboul Khair MD, Abdel-Salam AM, Abo-Elgheit A, Qubaisy H, Ali AM, Abdel-Mawgoud E. Effects of bovine colostrum on recurrent respiratory tract infections and diarrhea in children. Medicine (Baltimore). 2016 Sep;95(37):e4560. doi: 10.1097/MD.0000000000004560.
PMID: 27631207
citation: Halasa M, Maciejewska D, Baskiewicz-Halasa M, Machalinski B, Safranow K, Stachowska E. Oral Supplementation with Bovine Colostrum Decreases Intestinal Permeability and Stool Concentrations of Zonulin in Athletes. Nutrients. 2017 Apr 8;9(4):370. doi: 10.3390/nu9040370.
PMID: 28397754
citation: Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Cantrell JA, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Prophylactic Efficacy of Hyperimmune Bovine Colostral Antiadhesin Antibodies Against Enterotoxigenic Escherichia coli Diarrhea: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial. J Infect Dis. 2017 Jul 1;216(1):7-13. doi: 10.1093/infdis/jix144.
PMID: 28541500
responsible party type: Sponsor
mesh term: Growth Disorders
mesh term: Micronutrients
mesh term: Trace Elements
sharing ipd: No