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The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801317
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Project Peanut Butter
Kamuzu University of Health Sciences
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stunting Environmental Enteric Dysfunction Dietary Supplement: BC/ egg Dietary Supplement: Control Dietary Supplement: multiple micronutrient Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BC/ egg
4.3 grams egg powder + 5.7 grams bovine colostrum
 Dietary Supplement: BC/ egg
4.3 egg powder + 5.7 g bovine colostrum

Dietary Supplement: multiple micronutrient
multiple micronutrient sprinkle powder
Placebo Comparator: Control
15 grams corn-soya blend
 Dietary Supplement: Control
15 grams corn-soya blend

Dietary Supplement: multiple micronutrient
multiple micronutrient sprinkle powder


Outcome Measures
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Primary Outcome Measures :
  1. Intestinal permeability [ Time Frame: 12 weeks ]
    The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter

  2. Linear growth [ Time Frame: 12 weeks and 32 weeks ]
    Change in length expressed as anthropometric z-score from enrollment to end point


Secondary Outcome Measures :
  1. Incidence of diarrhea [ Time Frame: 12 weeks ]
    Caregiver report of number of days they child has diarrhea over the course of the study

  2. Adverse effects of the bovine colostrum/ egg [ Time Frame: 12 weeks ]
    Caregiver report of number of days they child has adverse effects over the course of the study

  3. 16S configuration of fecal microbiota [ Time Frame: 12 weeks ]
    Looking at the 16S configuration in stool samples collected

  4. Stunting [ Time Frame: 12 and 32 weeks ]
    Categorization of length-for-age z-scores

  5. Environmental enteric dysfunction [ Time Frame: 12 weeks ]
    Categorization of lactulose permeability measurements


Eligibility Criteria
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Ages Eligible for Study:   9 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Children at 9-10 months of age

Exclusion Criteria:

  • Malnutrition
  • congenital abnormalities
  • chronic diseases such as heart disease, cerebral palsy, or HIV infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801317


Locations
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Malawi
Project Peanut Butter, Malawi
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Project Peanut Butter
Kamuzu University of Health Sciences
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03801317    
Other Study ID Numbers: 201808199
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes
Micronutrients
Trace Elements
Physiological Effects of Drugs