Clinical trial NCT06002438: Eggs for Gut Health
Official title: Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition
Stunting
Environmental Enteric Dysfunction
Severe Acute Malnutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Project Peanut Butter
name: Thrasher Research Fund
name: Ministry of Health and Sanitation, Sierra Leone
First posted: 2023-08-21
Enrollment: 461
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent lactulose excretion
timeFrame: Collected 12 and 24 weeks after enrollment
measure: Change in length-for-age z-score
timeFrame: To be compared at 12 and 24 weeks after enrollment
Secondary outcomes:
measure: Percent Lactulose excretion >= 0.2 and >=0.45
timeFrame: Collected 6, 12, and 24 weeks after enrollment
measure: Rate of length gain
timeFrame: Across 24 week follow-up period
measure: LAZ < -2
timeFrame: To be compared at 12, 18, and 24 weeks after enrollment
measure: Fecal host mRNA transcripts
timeFrame: Collected 12 and 24 weeks after enrollment
measure: Fecal host protein alpha-1 antitrypsin
timeFrame: Collected 12 and 24 weeks after enrollment
measure: Fecal host protein myeloperoxidase
timeFrame: Collected 12 and 24 weeks after enrollment
measure: Fecal host protein neopterin
timeFrame: Collected 12 and 24 weeks after enrollment
measure: Rate of weight gain
timeFrame: Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period
measure: Percent Lactulose excretion
timeFrame: 6 weeks after enrollment
measure: Deterioration to severe acute malnutrition
timeFrame: Time-to-event across follow-up period
measure: Recurrence of MAM
timeFrame: Time-to-event across follow-up period
measure: Sustained recovery
timeFrame: Across 24 week follow-up period
measure: Death
timeFrame: Time-to-event across follow-up period
measure: Graduation
timeFrame: Within 6 weeks of enrollment
Other outcomes:
Locations:
city: Bandajuma
country: Sierra Leone
facility: Bandajuma
state: Southern
city: Bendu
country: Sierra Leone
facility: Bendu Maleh
state: Southern
city: Blama Massaquoi
country: Sierra Leone
facility: Blama Massaquoi
state: Southern
city: Gbondapi
country: Sierra Leone
facility: Gbondapi
state: Southern
city: Gofor
country: Sierra Leone
facility: Gofor
state: Southern
city: Jendema
country: Sierra Leone
facility: Jendema
state: Southern
city: Potoru
country: Sierra Leone
facility: Potoru
state: Southern
city: Pujehun
country: Sierra Leone
facility: Pujehun Static
state: Southern
city: Taninahun
country: Sierra Leone
facility: Taninahun
state: Southern
city: Zimmi
country: Sierra Leone
facility: Zimmi
state: Southern
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
References: