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The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

Primary Purpose

Stunting, Environmental Enteric Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
BC/ egg
Control
multiple micronutrient
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stunting

Eligibility Criteria

9 Months - 10 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Children at 9-10 months of age

Exclusion Criteria:

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

Sites / Locations

  • Project Peanut Butter, Malawi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BC/ egg

Control

Arm Description

4.3 grams egg powder + 5.7 grams bovine colostrum

15 grams corn-soya blend

Outcomes

Primary Outcome Measures

Intestinal permeability
The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
Linear growth
Change in length expressed as anthropometric z-score from enrollment to end point

Secondary Outcome Measures

Incidence of diarrhea
Caregiver report of number of days they child has diarrhea over the course of the study
Adverse effects of the bovine colostrum/ egg
Caregiver report of number of days they child has adverse effects over the course of the study
16S configuration of fecal microbiota
Looking at the 16S configuration in stool samples collected
Stunting
Categorization of length-for-age z-scores
Environmental enteric dysfunction
Categorization of lactulose permeability measurements

Full Information

First Posted
January 10, 2019
Last Updated
September 14, 2020
Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Kamuzu University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03801317
Brief Title
The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Official Title
The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Kamuzu University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine colostrum or a control flour along with a multiple micronutrient powder to the diets of healthy Malawian children 9 months of age. This supplement provides additional essential amino acids, choline and immunoactive colostrum. Children will be receive either the supplement or control for 12 weeks. Children will have regular follow-up where anthropometry is measured. At enrollment and after 12 weeks, stool will be collected and a urinary lactulose permeability test conducted. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Environmental Enteric Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BC/ egg
Arm Type
Experimental
Arm Description
4.3 grams egg powder + 5.7 grams bovine colostrum
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
15 grams corn-soya blend
Intervention Type
Dietary Supplement
Intervention Name(s)
BC/ egg
Intervention Description
4.3 egg powder + 5.7 g bovine colostrum
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
15 grams corn-soya blend
Intervention Type
Dietary Supplement
Intervention Name(s)
multiple micronutrient
Intervention Description
multiple micronutrient sprinkle powder
Primary Outcome Measure Information:
Title
Intestinal permeability
Description
The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
Time Frame
12 weeks
Title
Linear growth
Description
Change in length expressed as anthropometric z-score from enrollment to end point
Time Frame
12 weeks and 32 weeks
Secondary Outcome Measure Information:
Title
Incidence of diarrhea
Description
Caregiver report of number of days they child has diarrhea over the course of the study
Time Frame
12 weeks
Title
Adverse effects of the bovine colostrum/ egg
Description
Caregiver report of number of days they child has adverse effects over the course of the study
Time Frame
12 weeks
Title
16S configuration of fecal microbiota
Description
Looking at the 16S configuration in stool samples collected
Time Frame
12 weeks
Title
Stunting
Description
Categorization of length-for-age z-scores
Time Frame
12 and 32 weeks
Title
Environmental enteric dysfunction
Description
Categorization of lactulose permeability measurements
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Children at 9-10 months of age Exclusion Criteria: Malnutrition congenital abnormalities chronic diseases such as heart disease, cerebral palsy, or HIV infection
Facility Information:
Facility Name
Project Peanut Butter, Malawi
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27940670
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

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