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Trial record 27 of 110 for:    test | ( Map: Malawi )

Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

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ClinicalTrials.gov Identifier: NCT02925026
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Washington University School of Medicine

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 Not Applicable

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

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Linear Growth [ Time Frame: 16 weeks ]
    changes in linear growth



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Ages Eligible for Study:   12 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925026


Locations
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Malawi
Malawi
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Malawi
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02925026     History of Changes
Other Study ID Numbers: Lactoferrin-Lysozyme
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Lactoferrin
Muramidase
Anti-Infective Agents