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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02925026
Date of registration:	04/10/2016
Prospective Registration:	No
Primary sponsor:	Washington University School of Medicine
Public title:	Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Scientific title:
Date of first enrolment:	October 2016
Target sample size:	235
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02925026
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Malawi

Contacts

Name:	Chrissie Thakwalakwa, PhD
Address:
Telephone:
Email:
Affiliation:	Study Director

Name:	Indi Trehan, MD MPH DTM&H
Address:
Telephone:
Email:
Affiliation:	Washington University in St. Louis; University of Malawi

Name:	Mark J Manary, MD
Address:
Telephone:
Email:
Affiliation:	Washington University in St. Louis; University of Malawi

Key inclusion & exclusion criteria

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

Age minimum: 12 Months
Age maximum: 35 Months
Gender: All

Health Condition(s) or Problem(s) studied

Environmental Enteric Dysfunction

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Lysozyme

Dietary Supplement: Lactoferrin

Primary Outcome(s)

Dual Sugar Absorption Test [Time Frame: 8 weeks]

Dual Sugar Absorption Test [Time Frame: 16 weeks]

Secondary Outcome(s)

Mannitol Excretion [Time Frame: 16 weeks]

Lactulose Excretion [Time Frame: 16 weeks]

Lactulose Excretion [Time Frame: 8 weeks]

Mannitol Excretion [Time Frame: 8 weeks]

Secondary ID(s)

Lactoferrin-Lysozyme

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Malawi

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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