Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

Washington University School of Medicine235 enrolled

Overview

Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

235

Conditions

Environmental Enteric Dysfunction

Interventions

LactoferrinDIETARY_SUPPLEMENT

LysozymeDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Malawi

Blantyre, Malawi

Outcomes

Primary Outcomes

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 8 weeks

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 16 weeks

Secondary Outcomes

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 8 weeks

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 16 weeks

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 8 weeks

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.