Eggs for Gut Health
- Conditions
- Moderate Acute MalnutritionSevere Acute MalnutritionStuntingEnvironmental Enteric Dysfunction
- Interventions
- Dietary Supplement: Whole egg powderDietary Supplement: Corn powderDietary Supplement: Supercereal PlusDietary Supplement: Micronutrient sprinkles
- Registration Number
- NCT06002438
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 461
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Egg powder Micronutrient sprinkles 15g egg powder per day for 24 weeks Egg powder Whole egg powder 15g egg powder per day for 24 weeks Egg powder Supercereal Plus 15g egg powder per day for 24 weeks Corn powder Micronutrient sprinkles 15g corn powder per day for 24 weeks Egg powder Sulfadoxine pyrimethamine 15g egg powder per day for 24 weeks Corn powder Corn powder 15g corn powder per day for 24 weeks Corn powder Supercereal Plus 15g corn powder per day for 24 weeks Corn powder Sulfadoxine pyrimethamine 15g corn powder per day for 24 weeks
- Primary Outcome Measures
Name Time Method Percent lactulose excretion Collected 12 and 24 weeks after enrollment Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Change in length-for-age z-score To be compared at 12 and 24 weeks after enrollment Difference in length-for-age z-score between enrollment and weeks 12 and 24
- Secondary Outcome Measures
Name Time Method Fecal host mRNA transcripts Collected 12 and 24 weeks after enrollment CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
Recurrence of MAM Time-to-event across follow-up period Development of MUAC \< 12.5 cm among those who achieved MUAC \>= 12.5 cm during initial MAM treatment
Sustained recovery Across 24 week follow-up period Defined by achievement mid-upper arm circumference \>= 12.5 cm without nutritional edema and maintenance of MUAC \>= 12.5 cm throughout follow-up thereafter.
Graduation Within 6 weeks of enrollment Defined by mid-upper arm circumference \>= 12.5 cm
LAZ < -2 To be compared at 12, 18, and 24 weeks after enrollment Proportion stunted
Fecal host protein alpha-1 antitrypsin Collected 12 and 24 weeks after enrollment Level of alpha-1 antitrypsin, mg/g
Fecal host protein neopterin Collected 12 and 24 weeks after enrollment Level of neopterin, nmol/L
Fecal host protein myeloperoxidase Collected 12 and 24 weeks after enrollment Level of myeloperoxidase, ng/mL
Rate of weight gain Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period g/kg/d
Percent Lactulose excretion 6 weeks after enrollment Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Deterioration to severe acute malnutrition Time-to-event across follow-up period Mid-upper arm circumference \< 11.5 cm and/or nutritional edema
Percent Lactulose excretion >= 0.2 and >=0.45 Collected 6, 12, and 24 weeks after enrollment Proportion with moderately and severely abnormal small intestinal permeability. Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Rate of length gain Across 24 week follow-up period mm/week
Death Time-to-event across follow-up period As defined by caregiver report
Trial Locations
- Locations (10)
Bandajuma
🇸🇱Bandajuma, Southern, Sierra Leone
Bendu Maleh
🇸🇱Bendu, Southern, Sierra Leone
Blama Massaquoi
🇸🇱Blama Massaquoi, Southern, Sierra Leone
Gbondapi
🇸🇱Gbondapi, Southern, Sierra Leone
Gofor
🇸🇱Gofor, Southern, Sierra Leone
Jendema
🇸🇱Jendema, Southern, Sierra Leone
Potoru
🇸🇱Potoru, Southern, Sierra Leone
Pujehun Static
🇸🇱Pujehun, Southern, Sierra Leone
Taninahun
🇸🇱Taninahun, Southern, Sierra Leone
Zimmi
🇸🇱Zimmi, Southern, Sierra Leone