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

September 14, 2020 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Project Peanut Butter, Malawi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BC/ egg
4.3 grams egg powder + 5.7 grams bovine colostrum
Dietary supplement: BC/ egg
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: multiple micronutrient
multiple micronutrient sprinkle powder
Dietary supplement: Control
15 grams corn-soya blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal permeability
Time Frame: 12 weeks
The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
12 weeks
Linear growth
Time Frame: 12 weeks and 32 weeks
Change in length expressed as anthropometric z-score from enrollment to end point
12 weeks and 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diarrhea
Time Frame: 12 weeks
Caregiver report of number of days they child has diarrhea over the course of the study
12 weeks
Adverse effects of the bovine colostrum/ egg
Time Frame: 12 weeks
Caregiver report of number of days they child has adverse effects over the course of the study
12 weeks
16S configuration of fecal microbiota
Time Frame: 12 weeks
Looking at the 16S configuration in stool samples collected
12 weeks
Stunting
Time Frame: 12 and 32 weeks
Categorization of length-for-age z-scores
12 and 32 weeks
Environmental enteric dysfunction
Time Frame: 12 weeks
Categorization of lactulose permeability measurements
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Kamuzu University of Health Sciences
Project Peanut Butter

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201808199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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