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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stunting, Environmental Enteric Dysfunction

Intervention / Treatment
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* Dietary Supplement: BC/ egg
* Dietary Supplement: Control
* Dietary Supplement: multiple micronutrient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 10 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BC/ egg<br>4.3 grams egg powder + 5.7 grams bovine colostrum | Dietary Supplement: BC/ egg<br>* 4.3 egg powder + 5.7 g bovine colostrum<br>Dietary Supplement: multiple micronutrient<br>* multiple micronutrient sprinkle powder<br>|
| Placebo Comparator: Control<br>15 grams corn-soya blend | Dietary Supplement: Control<br>* 15 grams corn-soya blend<br>Dietary Supplement: multiple micronutrient<br>* multiple micronutrient sprinkle powder<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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