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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
278
4.3 egg powder + 5.7 g bovine colostrum
15 grams corn-soya blend
multiple micronutrient sprinkle powder
Project Peanut Butter, Malawi
Blantyre, Malawi
Intestinal permeability
The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
Time frame: 12 weeks
Linear growth
Change in length expressed as anthropometric z-score from enrollment to end point
Time frame: 12 weeks and 32 weeks
Incidence of diarrhea
Caregiver report of number of days they child has diarrhea over the course of the study
Time frame: 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
Time frame: 12 weeks
16S configuration of fecal microbiota
Looking at the 16S configuration in stool samples collected
Time frame: 12 weeks
Stunting
Categorization of length-for-age z-scores
Time frame: 12 and 32 weeks
Environmental enteric dysfunction
Categorization of lactulose permeability measurements
Time frame: 12 weeks
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