Clinical trial NCT03801317: The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Official title: The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Environmental Enteric Dysfunction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Project Peanut Butter
name: Kamuzu University of Health Sciences
First posted: 2019-01-11
Enrollment: 278
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Intestinal permeability
timeFrame: 12 weeks
measure: Linear growth
timeFrame: 12 weeks and 32 weeks
Secondary outcomes:
measure: Incidence of diarrhea
timeFrame: 12 weeks
measure: Adverse effects of the bovine colostrum/ egg
timeFrame: 12 weeks
measure: 16S configuration of fecal microbiota
timeFrame: 12 weeks
measure: Stunting
timeFrame: 12 and 32 weeks
measure: Environmental enteric dysfunction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Project Peanut Butter, Malawi
Study officials:
References:
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