MedTrace Logo

Eggs for Gut Health

NCT06002438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2025-02-06

No results posted yet for this study

Summary

The goal of this clinical trial is to test egg powder supplementation in children with moderate acute malnutrition in Sierra Leone. The main question it aims to answer is:

\- Will provision of 15g of whole egg powder per day during and after treatment for moderate acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear growth among 6-30 month old Sierra Leonean children compared with daily corn powder supplementation?

Conditions

  • Moderate Acute Malnutrition
  • Stunting
  • Environmental Enteric Dysfunction
  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Whole egg powder

15g daily dose for 24 weeks

DIETARY_SUPPLEMENT

Corn powder

15g daily dose for 24 weeks

DIETARY_SUPPLEMENT

Supercereal Plus

Approximately 110 g per day (1.5 kg every 2 weeks) supplementary food to be provided for treatment of MAM for up to 6 weeks.

DIETARY_SUPPLEMENT

Micronutrient sprinkles

To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.

DRUG

Sulfadoxine pyrimethamine

Infants \< 12 months of age: 250/12.5mg SP at enrollment, week 6, week 12, week 18. Infants \>= 12 months of age: 500/25mg SP at enrollment, week 6, week 12, week 18.

Sponsors & Collaborators

  • Project Peanut Butter

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Ministry of Health and Sanitation, Sierra Leone

    collaborator OTHER_GOV

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • Sierra Leone

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002438 on ClinicalTrials.gov