Environmental Enteric Dysfunction
Conditions
Brief summary
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
Interventions
Sponsors
University of Malawi
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* children aged 12-35 months * youngest eligible child in each household
Exclusion criteria
* severe or moderate acute malnutrition * severe chronic illness * children unable to drink 20 mL of dual sugar solution * children in need of acute medical treatment for illness or injury at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dual Sugar Absorption Test | 8 weeks | lactulose-mannitol ratio in urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lactulose Excretion | 8 weeks | percentage of ingested lactulose excreted in urine |
| Mannitol Excretion | 8 weeks | percentage of ingested mannitol excreted in urine |
Other
| Measure | Time frame | Description |
|---|---|---|
| Linear Growth | 16 weeks | changes in linear growth |
Countries
Malawi
Outcome results
None listed