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Clinical Effectiveness Trial of PTM1001 to Reduce Stunting and Ameliorate Environmental Enteric Dysfunction in Malawian Infants

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ClinicalTrials.gov Identifier: NCT03801317
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Project Peanut Butter
University of Malawi College of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The trial will consist of adding a supplement called PTM1001(4.3 egg powder + 5.7 g bovine colostrum) along with a multiple micronutrient powder to the diet of children 10-13 months of age. This should improve linear growth and gut health. Children will be receive either the supplement or control for 12 weeks. At enrollment at at week 12 stool and urine will be collected. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.

Condition or disease Intervention/treatment Phase
Stunting Environmental Enteric Dysfunction Dietary Supplement: PTM1001 Dietary Supplement: Control Dietary Supplement: multiple micronutrient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Effectiveness Trial of PTM1001 to Reduce Stunting and Ameliorate Environmental Enteric Dysfunction in Malawian Infants
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Arm Intervention/treatment
Experimental: PTM1001
4.3 grams egg powder + 5.7 grams bovine colostrum
Dietary Supplement: PTM1001
4.3 egg powder + 5.7 g bovine colostrum

Dietary Supplement: multiple micronutrient
multiple micronutrient sprinkle powder

Placebo Comparator: Control
15 grams corn-soya blend
Dietary Supplement: Control
15 grams corn-soya blend

Dietary Supplement: multiple micronutrient
multiple micronutrient sprinkle powder




Primary Outcome Measures :
  1. linear growth [ Time Frame: 12 weeks ]
    change in length-for-age z-score


Secondary Outcome Measures :
  1. Percent lactulose excretion [ Time Frame: 12 weeks ]
    The dual sugar permeability test (the lactulose-mannitol test) involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter



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Ages Eligible for Study:   10 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Children at 10 months of age

Exclusion Criteria:

  • Malnutrition
  • congenital abnormalities
  • chronic diseases such as heart disease, cerebral palsy, or HIV infection

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): NCT03801317


Contacts
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Contact: Mark Manary, MD 314 454-2178 manarymj@wustl.edu

Locations
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Malawi
Project Peanut Butter, Malawi Recruiting
Blantyre, Malawi
Contact: Mark Manary, MD    (314) 454-2178    manarymj@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Project Peanut Butter
University of Malawi College of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03801317     History of Changes
Other Study ID Numbers: 201808199
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs