Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02925026
• Collaborator: University of Malawi (Other)
• Enrollment: 235
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteric Dysfunction	Dietary Supplement: Lactoferrin; Dietary Supplement: Lysozyme; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactoferrin+Lysozyme lactoferrin and lysozyme in rice flour	Dietary Supplement: Lactoferrin; Dietary Supplement: Lysozyme
Placebo Comparator: Placebo rice flour	Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

1. Dual Sugar Absorption Test [8 weeks]

   lactulose-mannitol ratio in urine

2. Dual Sugar Absorption Test [16 weeks]

   lactulose-mannitol ratio in urine

Secondary Outcome Measures

1. Lactulose Excretion [8 weeks]

   percentage of ingested lactulose excreted in urine

2. Lactulose Excretion [16 weeks]

   percentage of ingested lactulose excreted in urine

3. Mannitol Excretion [8 weeks]

   percentage of ingested mannitol excreted in urine

4. Mannitol Excretion [16 weeks]

   percentage of ingested mannitol excreted in urine

Other Outcome Measures

1. Linear Growth [16 weeks]

   changes in linear growth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 35 Months
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malawi	Blantyre		Malawi

Sponsors and Collaborators

• Washington University School of Medicine
• University of Malawi

Investigators

• Principal Investigator: Mark J Manary, MD, Washington University in St. Louis; University of Malawi
• Study Director: Chrissie Thakwalakwa, PhD, Study Director
• Study Director: Indi Trehan, MD MPH DTM&H, Washington University in St. Louis; University of Malawi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02925026
• Other Study ID Numbers: Lactoferrin-Lysozyme
• First Posted: Oct 5, 2016
• Last Update Posted: May 2, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Lactoferrin

Study Results

No Results Posted as of May 2, 2018