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OpenTrials
Completed

NCT Number: NCT03801317

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

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.

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Key information

Conditions

Stunting Environmental Enteric Dysfunction Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 month–10 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Peanut Butter, Malawi

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BC/ egg

Dietary Supplement

4.3 egg powder + 5.7 g bovine colostrum

Control

Dietary Supplement

15 grams corn-soya blend

Multiple micronutrient

Dietary Supplement

multiple micronutrient sprinkle powder

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Kamuzu University of Health Sciences
  • Project Peanut Butter

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 11, 2019
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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