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

Not Applicable

Completed

• Conditions: Environmental Enteric Dysfunction; Stunting
• Interventions: Dietary Supplement: BC/ egg; Dietary Supplement: Control; Dietary Supplement: multiple micronutrient

• Registration Number: NCT03801317
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Primary Completion: 2019-12-30
• Study Completion: 2020-05-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Healthy Children at 9-10 months of age

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Exclusion Criteria

• Malnutrition
• congenital abnormalities
• chronic diseases such as heart disease, cerebral palsy, or HIV infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BC/ egg	BC/ egg	4.3 grams egg powder + 5.7 grams bovine colostrum
Control	multiple micronutrient	15 grams corn-soya blend
BC/ egg	multiple micronutrient	4.3 grams egg powder + 5.7 grams bovine colostrum
Control	Control	15 grams corn-soya blend

Primary Outcome Measures

Name	Time	Method
Intestinal permeability	12 weeks	The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
Linear growth	12 weeks and 32 weeks	Change in length expressed as anthropometric z-score from enrollment to end point

Secondary Outcome Measures

Name	Time	Method
Adverse effects of the bovine colostrum/ egg	12 weeks	Caregiver report of number of days they child has adverse effects over the course of the study
Stunting	12 and 32 weeks	Categorization of length-for-age z-scores
Incidence of diarrhea	12 weeks	Caregiver report of number of days they child has diarrhea over the course of the study
16S configuration of fecal microbiota	12 weeks	Looking at the 16S configuration in stool samples collected
Environmental enteric dysfunction	12 weeks	Categorization of lactulose permeability measurements

Trial Locations

Locations (1)

Project Peanut Butter, Malawi; 🇲🇼 Blantyre, Malawi