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OpenTrials
Completed

NCT Number: NCT02925026

Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

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

Completed

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Key information

Conditions

Environmental Enteric Dysfunction

Age range

12 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malawi

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactoferrin

Dietary Supplement

Lysozyme

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Dual Sugar Absorption Test

    Time frame: 8 weeks

    lactulose-mannitol ratio in urine

  2. Dual Sugar Absorption Test

    Time frame: 16 weeks

    lactulose-mannitol ratio in urine

Secondary outcomes

  1. Lactulose Excretion

    Time frame: 8 weeks

    percentage of ingested lactulose excreted in urine

  2. Lactulose Excretion

    Time frame: 16 weeks

    percentage of ingested lactulose excreted in urine

  3. Mannitol Excretion

    Time frame: 8 weeks

    percentage of ingested mannitol excreted in urine

  4. Mannitol Excretion

    Time frame: 16 weeks

    percentage of ingested mannitol excreted in urine

Other outcomes

  1. Linear Growth

    Time frame: 16 weeks

    changes in linear growth

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Malawi

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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