Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

NCT ID: NCT02925026

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Environmental Enteric Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactoferrin+Lysozyme

lactoferrin and lysozyme in rice flour

Group Type EXPERIMENTAL

Lactoferrin

Intervention Type DIETARY_SUPPLEMENT

Lysozyme

Intervention Type DIETARY_SUPPLEMENT

Placebo

rice flour

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Lactoferrin

Intervention Type DIETARY_SUPPLEMENT

Lysozyme

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malawi

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University in St. Louis; University of Malawi

Chrissie Thakwalakwa, PhD

Role: STUDY_DIRECTOR

Study Director

Indi Trehan, MD MPH DTM&H

Role: STUDY_DIRECTOR

Washington University in St. Louis; University of Malawi

Locations

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Malawi

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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Cheng WD, Wold KJ, Benzoni NS, Thakwalakwa C, Maleta KM, Manary MJ, Trehan I. Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial. Trials. 2017 Nov 6;18(1):523. doi: 10.1186/s13063-017-2278-8.

Reference Type DERIVED
PMID: 29110675 (View on PubMed)

Other Identifiers

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Lactoferrin-Lysozyme

Identifier Type: -

Identifier Source: org_study_id

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