Eggs for Gut Health

NCT ID: NCT06002438

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 461 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-12-19

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?

Detailed Description

Undernutrition in children manifests as wasting, stunting, or both. While wasting is generally responsive to high-quality nutritional interventions, stunting is less so. Affected children are at increased risk of acute and chronic illnesses, have reduced neurocognitive development, lower academic achievement, reduced adult earning potential, and shortened lifespans. Given that stunting affects over 140 million children at any one time, the costs incurred are deep and broad, particularly among children in sub-Saharan Africa, where nearly half of the world's population growth is expected to occur over the next 30 years. Part of the challenge of treating stunting has been attributed to environmental enteric dysfunction (EED), an acquired small intestine disorder characterized by chronic inflammation, villus blunting, and impaired nutrient absorption. EED is prevalent in the same populations plagued by stunting, develops concurrently with loss in linear growth, and has explained upwards of 43% of observed growth faltering. EED has recently also been found in over 75% of children with moderate acute malnutrition (MAM, moderate wasting) in Sierra Leone, a population with high rates of deterioration to severe acute malnutrition and death, 20%. EED is a plausible cause for this treatment resistance, and for the high rates of recurrence seen in these children. There is an urgent need to increase understanding of the concurrence of stunting, EED, and wasting, and to test interventions targeted to their pathological underpinnings. Dietary egg can play a critical role in the fight against malnutrition by providing abundant high-quality protein and nutrients essential for physical and cognitive recovery. One egg/day has been shown to reduce stunting in several contexts. Recent evidence has shown that short-term egg/bovine colostrum supplement given to 9-12-month-old Malawian children improved linear growth and intestinal permeability in children with severe EED. It is possible that prolonged supplementation with egg in a high-risk population in rural Sierra Leone could improve acute and long-term health trajectories for children and put eggs on the map for food aid. This will be a randomized, investigator-blinded, controlled clinical trial testing whether daily supplementation with 15g whole egg powder during and for 18 weeks after treatment for moderate acute malnutrition might reduce intestinal permeability and improve linear growth, among other outcomes, when compared with control corn powder. Children with relatively higher risk MAM will be enrolled (MUAC < 12.5 cm AND MUACz < -2), treated with Supercereal Plus for up to 6 weeks, and undergo urine and stool collections at 6, 12, and 24 weeks. Urine collections will be for assessment of lactulose permeability and will involve participant consumption of a known amount of lactulose and collection of all urine over at least 4 hours thereafter. Stool collections will be for fecal host mRNA transcripts and selected proteins. Participants will also receive intermittent malaria chemoprophylaxis.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Egg powder

15g egg powder per day for 24 weeks

Group Type: EXPERIMENTAL

Whole egg powder

Intervention Type: DIETARY_SUPPLEMENT

15g daily dose for 24 weeks

Supercereal Plus

Intervention Type: DIETARY_SUPPLEMENT

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.

Micronutrient sprinkles

Intervention Type: DIETARY_SUPPLEMENT

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

Sulfadoxine pyrimethamine

Intervention Type: DRUG

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.

Corn powder

15g corn powder per day for 24 weeks

Group Type: ACTIVE_COMPARATOR

Corn powder

Intervention Type: DIETARY_SUPPLEMENT

15g daily dose for 24 weeks

Supercereal Plus

Intervention Type: DIETARY_SUPPLEMENT

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.

Micronutrient sprinkles

Intervention Type: DIETARY_SUPPLEMENT

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

Sulfadoxine pyrimethamine

Intervention Type: DRUG

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.

Interventions

Whole egg powder

15g daily dose for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Corn powder

15g daily dose for 24 weeks

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient sprinkles

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

Other Intervention Names

SP

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Project Peanut Butter

OTHER

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Ministry of Health and Sanitation, Sierra Leone

OTHER_GOV

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

Countries

Sierra Leone

Other Identifiers

202306090

Identifier Type: -

Identifier Source: org_study_id