Environmental Enteric Dysfunction, Stunting
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBC/ egg
4.3 egg powder + 5.7 g bovine colostrum
DIETARY_SUPPLEMENTControl
15 grams corn-soya blend
DIETARY_SUPPLEMENTmultiple micronutrient
multiple micronutrient sprinkle powder
Sponsors
Project Peanut Butter
Kamuzu University of Health Sciences
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 10 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diarrhea | 12 weeks | Caregiver report of number of days they child has diarrhea over the course of the study |
| 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 |
| 16S configuration of fecal microbiota | 12 weeks | Looking at the 16S configuration in stool samples collected |
| Stunting | 12 and 32 weeks | Categorization of length-for-age z-scores |
| Environmental enteric dysfunction | 12 weeks | Categorization of lactulose permeability measurements |
Countries
Malawi
Outcome results
None listed