Moderate Acute MalnutritionNCT06002438
Eggs for Gut Health
A study testing Whole egg powder, Corn powder and Supercereal Plus in people with Moderate Acute Malnutrition and Stunting, run by Washington University School of Medicine at 10 sites in Sierra Leone.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 30 months
- Conditions the study is for
- Moderate Acute Malnutrition, Stunting, Environmental Enteric Dysfunction
- What is being tested?
- Whole egg powder, Corn powder and Supercereal Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 10 sitesSierra Leone
- Study dates
- 9 Oct 2023to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Sierra Leone10 sites
Bandajuma
Bandajuma, Southern Province
Bendu Maleh
Bendu, Southern Province
Blama Massaquoi
Blama Massaquoi, Southern Province
Gbondapi
Gbondapi, Southern Province
Gofor
Gofor, Southern Province
Jendema
Jendema, Southern Province
Potoru
Potoru, Southern Province
Pujehun Static
Pujehun, Southern Province
Taninahun
Taninahun, Southern Province
Zimmi
Zimmi, Southern Province
About this study
Official title: Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
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?
Read the 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
- Being tested
- Whole egg powder, Corn powder, Supercereal Plus, Micronutrient sprinkles, Sulfadoxine pyrimethamine
- Medical subject headings
- Growth Disorders, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole egg powderDietary supplement
15g daily dose for 24 weeks
Corn powderDietary supplement
15g daily dose for 24 weeks
Supercereal PlusDietary 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 sprinklesDietary supplement
To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.
Sulfadoxine pyrimethamineDrug
Also called SP
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.
| Study group | Role | What they receive |
|---|---|---|
| Egg powder | Experimental | 15g egg powder per day for 24 weeks Receives: Dietary Supplement: Whole egg powder; Dietary Supplement: Supercereal Plus; Dietary Supplement: Micronutrient sprinkles; Drug: Sulfadoxine pyrimethamine |
| Corn powder | Active comparator | 15g corn powder per day for 24 weeks Receives: Dietary Supplement: Corn powder; Dietary Supplement: Supercereal Plus; Dietary Supplement: Micronutrient sprinkles; Drug: Sulfadoxine pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent lactulose excretion
Percent lactulose excretion in urine over >=4 hours after lactulose consumption
Measured: 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
Measured: To be compared at 12 and 24 weeks after enrollment
Secondary outcomes (14)
Percent Lactulose excretion >= 0.2 and >=0.45
Proportion with moderately and severely abnormal small intestinal permeability. Percent lactulose excretion in urine over >=4 hours after lactulose consumption
Measured: Collected 6, 12, and 24 weeks after enrollment
Rate of length gain
mm/week
Measured: Across 24 week follow-up period
LAZ < -2
Proportion stunted
Measured: To be compared at 12, 18, and 24 weeks after enrollment
Fecal host mRNA transcripts
CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
Measured: Collected 12 and 24 weeks after enrollment
Fecal host protein alpha-1 antitrypsin
Level of alpha-1 antitrypsin, mg/g
Measured: Collected 12 and 24 weeks after enrollment
Fecal host protein myeloperoxidase
Level of myeloperoxidase, ng/mL
Measured: Collected 12 and 24 weeks after enrollment
Fecal host protein neopterin
Level of neopterin, nmol/L
Measured: Collected 12 and 24 weeks after enrollment
Rate of weight gain
g/kg/d
Measured: Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period
Percent Lactulose excretion
Percent lactulose excretion in urine over >=4 hours after lactulose consumption
Measured: 6 weeks after enrollment
Deterioration to severe acute malnutrition
Mid-upper arm circumference < 11.5 cm and/or nutritional edema
Measured: Time-to-event across follow-up period
Recurrence of MAM
Development of MUAC < 12.5 cm among those who achieved MUAC >= 12.5 cm during initial MAM treatment
Measured: Time-to-event across follow-up period
Sustained recovery
Defined by achievement mid-upper arm circumference >= 12.5 cm without nutritional edema and maintenance of MUAC >= 12.5 cm throughout follow-up thereafter.
Measured: Across 24 week follow-up period
Death
As defined by caregiver report
Measured: Time-to-event across follow-up period
Graduation
Defined by mid-upper arm circumference >= 12.5 cm
Measured: Within 6 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Oct 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Project Peanut Butter, Thrasher Research Fund, Ministry of Health and Sanitation, Sierra Leone
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002438
- Sponsor's protocol ID
- 202306090
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41193034
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
- ClinicalTrials.gov ID
- NCT06002438
- Acronym / sponsor ID
- 202306090
- Conditions
- Moderate Acute Malnutrition, Stunting, Environmental Enteric Dysfunction, Severe Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Project Peanut Butter, Thrasher Research Fund, Ministry of Health and Sanitation, Sierra Leone
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg powder | Experimental | Dietary Supplement: Whole egg powder, Dietary Supplement: Supercereal Plus, Dietary Supplement: Micronutrient sprinkles, Drug: Sulfadoxine pyrimethamine15g egg powder per day for 24 weeks |
| Corn powder | Active comparator | Dietary Supplement: Corn powder, Dietary Supplement: Supercereal Plus, Dietary Supplement: Micronutrient sprinkles, Drug: Sulfadoxine pyrimethamine15g corn powder per day for 24 weeks |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole egg powder15g daily dose for 24 weeks | Dietary supplement | Egg powder |
| Corn powder15g daily dose for 24 weeks | Dietary supplement | Corn powder |
| Supercereal PlusApproximately 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 | Corn powder, Egg powder |
| Micronutrient sprinklesTo be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients. | Dietary supplement | Corn powder, Egg powder |
| Sulfadoxine pyrimethamineAlso: SPInfants < 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. | Drug | Corn powder, Egg powder |
Primary outcome
Percent lactulose excretion
Time frame: 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
Time frame: To be compared at 12 and 24 weeks after enrollment
Difference in length-for-age z-score between enrollment and weeks 12 and 24
14 secondary outcomes
Percent Lactulose excretion >= 0.2 and >=0.45
Time frame: Collected 6, 12, and 24 weeks after enrollment
Rate of length gain
Time frame: Across 24 week follow-up period
LAZ < -2
Time frame: To be compared at 12, 18, and 24 weeks after enrollment
Fecal host mRNA transcripts
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein alpha-1 antitrypsin
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein myeloperoxidase
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein neopterin
Time frame: Collected 12 and 24 weeks after enrollment
Rate of weight gain
Time frame: Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period
Percent Lactulose excretion
Time frame: 6 weeks after enrollment
Deterioration to severe acute malnutrition
Time frame: Time-to-event across follow-up period
Recurrence of MAM
Time frame: Time-to-event across follow-up period
Sustained recovery
Time frame: Across 24 week follow-up period
Death
Time frame: Time-to-event across follow-up period
Graduation
Time frame: Within 6 weeks of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 41193034Stephenson 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.
- Individual participant dataSharing planned: Yes
Related trials for Moderate Acute Malnutrition
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
Not yet recruiting
Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Manary, MD principal investigator
Washington University School of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole egg powder, Corn powder and Supercereal Plus in people with Moderate Acute Malnutrition and Stunting, run by Washington University School of Medicine at 10 sites in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent lactulose excretion (time frame: Collected 12 and 24 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.