NCT02925026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

October 4, 2016

Last Update Submit

May 1, 2018

Conditions

Environmental Enteric Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Dual Sugar Absorption Test

    lactulose-mannitol ratio in urine

    8 weeks

  • Dual Sugar Absorption Test

    lactulose-mannitol ratio in urine

    16 weeks

Secondary Outcomes (4)

  • Lactulose Excretion

    8 weeks

  • Lactulose Excretion

    16 weeks

  • Mannitol Excretion

    8 weeks

  • Mannitol Excretion

    16 weeks

Other Outcomes (1)

  • Linear Growth

    16 weeks

Study Arms (2)

Lactoferrin+Lysozyme

EXPERIMENTAL

lactoferrin and lysozyme in rice flour

Dietary Supplement: LactoferrinDietary Supplement: Lysozyme

Placebo

PLACEBO COMPARATOR

rice flour

Dietary Supplement: Placebo

Interventions

LactoferrinDIETARY_SUPPLEMENT
Lactoferrin+Lysozyme
LysozymeDIETARY_SUPPLEMENT
Lactoferrin+Lysozyme
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age12 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malawi

Blantyre, Malawi

Location

Related Publications (1)

  • 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.

    PMID: 29110675DERIVED

MeSH Terms

Interventions

LactoferrinMuramidase

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteinsGlycoside Hydrolases

Study Officials

  • Mark J Manary, MD

    Washington University in St. Louis; University of Malawi

    PRINCIPAL INVESTIGATOR

  • Chrissie Thakwalakwa, PhD

    Study Director

    STUDY DIRECTOR

  • Indi Trehan, MD MPH DTM&H

    Washington University in St. Louis; University of Malawi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

MA(1)