Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

Not Applicable

Completed

• Conditions: Environmental Enteric Dysfunction
• Interventions: Dietary Supplement: Lactoferrin; Dietary Supplement: Placebo; Dietary Supplement: Lysozyme

• Registration Number: NCT02925026
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• children aged 12-35 months
• youngest eligible child in each household

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin+Lysozyme	Lysozyme	lactoferrin and lysozyme in rice flour
Lactoferrin+Lysozyme	Lactoferrin	lactoferrin and lysozyme in rice flour
Placebo	Placebo	rice flour

Primary Outcome Measures

Name	Time	Method
Dual Sugar Absorption Test	16 weeks	lactulose-mannitol ratio in urine

Secondary Outcome Measures

Name	Time	Method
Lactulose Excretion	16 weeks	percentage of ingested lactulose excreted in urine
Mannitol Excretion	16 weeks	percentage of ingested mannitol excreted in urine

Trial Locations

Locations (1)

Malawi; 🇲🇼 Blantyre, Malawi