Eggs for Gut Health
Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
1 other identifier
interventional
461
1 country
10
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2024
CompletedFebruary 6, 2025
February 1, 2025
1.2 years
August 10, 2023
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percent lactulose excretion
Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Collected 12 and 24 weeks after enrollment
Change in length-for-age z-score
Difference in length-for-age z-score between enrollment and weeks 12 and 24
To be compared at 12 and 24 weeks after enrollment
Secondary Outcomes (14)
Percent Lactulose excretion >= 0.2 and >=0.45
Collected 6, 12, and 24 weeks after enrollment
Rate of length gain
Across 24 week follow-up period
LAZ < -2
To be compared at 12, 18, and 24 weeks after enrollment
Fecal host mRNA transcripts
Collected 12 and 24 weeks after enrollment
Fecal host protein alpha-1 antitrypsin
Collected 12 and 24 weeks after enrollment
- +9 more secondary outcomes
Study Arms (2)
Egg powder
EXPERIMENTAL15g egg powder per day for 24 weeks
Corn powder
ACTIVE COMPARATOR15g corn powder per day for 24 weeks
Interventions
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.
To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.
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.
Eligibility Criteria
You may qualify if:
- At least 6 months of age and less than 30 months of age
- Mid-upper arm circumference \>= 11.5cm and \< 12. 5 cm
- Mid-upper arm circumference-for-age z-score \< -2
- Provision of signed (or thumb-printed) and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
You may not qualify if:
- Nutritional edema
- Simultaneous involvement in another research trial or supplementary feeding program
- Chronic debilitating illness
- Allergy to egg
- Receipt of treatment for acute malnutrition within 1 month prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Project Peanut Buttercollaborator
- Thrasher Research Fundcollaborator
- Ministry of Health and Sanitation, Sierra Leonecollaborator
Study Sites (10)
Bandajuma
Bandajuma, Southern Province, Sierra Leone
Bendu Maleh
Bendu, Southern Province, Sierra Leone
Blama Massaquoi
Blama Massaquoi, Southern Province, Sierra Leone
Gbondapi
Gbondapi, Southern Province, Sierra Leone
Gofor
Gofor, Southern Province, Sierra Leone
Jendema
Jendema, Southern Province, Sierra Leone
Potoru
Potoru, Southern Province, Sierra Leone
Pujehun Static
Pujehun, Southern Province, Sierra Leone
Taninahun
Taninahun, Southern Province, Sierra Leone
Zimmi
Zimmi, Southern Province, Sierra Leone
Related Publications (1)
Stephenson KB, Greenfeld A, Ryan MG, Kleban E, Kwak L, Lee A, Wegner DR, Jiang X, Hendrixson DT, Kamara MT, Koroma AS, Manary MJ. Egg supplementation for 24 weeks does not improve linear growth or reduce small intestinal permeability in Sierra Leonean children with moderate wasting: a randomized, blinded, controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1326-1337. doi: 10.1016/j.ajcnut.2025.08.019. Epub 2025 Oct 14.
PMID: 41193034DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Manary, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The intervention and control powders will be packaged such that investigators and outcomes assessors will not know their identity. Participants and care providers are likely to be able to distinguish them, however.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 21, 2023
Study Start
October 9, 2023
Primary Completion
December 19, 2024
Study Completion
December 19, 2024
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Within 12 months of primary publication