NCT02925026CompletedNot Applicable
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Washington University School of Medicine1 site in 1 country235 target enrollmentStarted: October 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 235
- Locations
- 1
- Primary Endpoint
- Dual Sugar Absorption Test
Study Overview
Brief Summary
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 35 Months (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo
Placebo Comparator
rice flour
Intervention: Placebo (Dietary Supplement)
Lactoferrin+Lysozyme
Experimental
lactoferrin and lysozyme in rice flour
Intervention: Lactoferrin (Dietary Supplement)
Lactoferrin+Lysozyme
Experimental
lactoferrin and lysozyme in rice flour
Intervention: Lysozyme (Dietary Supplement)
Outcomes
Primary Outcomes
Dual Sugar Absorption Test
Time Frame: 16 weeks
lactulose-mannitol ratio in urine
Secondary Outcomes
- Lactulose Excretion(16 weeks)
- Mannitol Excretion(16 weeks)
Investigators
Study Sites (1)
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