Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

Environmental Enteric Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925026
• Other study ID #: Lactoferrin-Lysozyme
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction

Intervention

Dietary Supplement:
• Lactoferrin

• Lysozyme

• Placebo

Locations

Country	Name	City	State
Malawi	Malawi	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Linear Growth	changes in linear growth	16 weeks
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	8 weeks
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	16 weeks
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	8 weeks
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	16 weeks
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	8 weeks
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	16 weeks