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Eggs for Gut Health

Primary Purpose

Moderate Acute Malnutrition, Stunting, Environmental Enteric Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Sierra Leone
Study Type
Interventional
Intervention
Whole egg powder
Corn powder
Supercereal Plus
Micronutrient sprinkles
Sulfadoxine pyrimethamine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Acute Malnutrition

Eligibility Criteria

6 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BandajumaRecruiting
  • Bendu MalehRecruiting
  • Blama MassaquoiRecruiting
  • GbondapiRecruiting
  • GoforRecruiting
  • JendemaRecruiting
  • PotoruRecruiting
  • Pujehun StaticRecruiting
  • TaninahunRecruiting
  • ZimmiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Egg powder

Corn powder

Arm Description

15g egg powder per day for 24 weeks

15g corn powder per day for 24 weeks

Outcomes

Primary Outcome Measures

Percent lactulose excretion
% lactulose excretion in urine over >=4 hours after lactulose consumption
Change in length-for-age z-score
Difference in length-for-age z-score between enrollment and weeks 12 and 24. Covariate will be baseline LAZ.

Secondary Outcome Measures

% Lactulose excretion >= 0.2 and >=0.45
Proportion with moderately and severely abnormal small intestinal permeability
Rate of length gain
mm/week
LAZ < -2
Proportion stunted
Fecal host mRNA transcripts
CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
Fecal host proteins MPO, AAT, NEO
Myeloperoxidase, alpha-1 antitrypsin, neopterin
Rate of weight gain
g/kg/d
% Lactulose excretion
Deterioration to severe acute malnutrition or death
Mid-upper arm circumference < 11.5 cm or nutritional edema
Recurrence of MAM
MUAC < 12.5 cm
Sustained recovery
Mid-upper arm circumference >= 12.5 cm without nutritional edema

Full Information

First Posted
August 10, 2023
Last Updated
October 18, 2023
Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Thrasher Research Fund, Ministry of Health and Sanitation, Sierra Leone
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1. Study Identification

Unique Protocol Identification Number
NCT06002438
Brief Title
Eggs for Gut Health
Official Title
Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Thrasher Research Fund, Ministry of Health and Sanitation, Sierra Leone

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Acute Malnutrition, Stunting, Environmental Enteric Dysfunction, Severe Acute Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Egg powder
Arm Type
Experimental
Arm Description
15g egg powder per day for 24 weeks
Arm Title
Corn powder
Arm Type
Active Comparator
Arm Description
15g corn powder per day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole egg powder
Intervention Description
15g daily dose for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn powder
Intervention Description
15g daily dose for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Supercereal Plus
Intervention Description
Approximately 110 g per day (1.5 kg every 2 weeks) supplementary food to be provided for treatment of MAM for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient sprinkles
Intervention Description
To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine pyrimethamine
Other Intervention Name(s)
SP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent lactulose excretion
Description
% lactulose excretion in urine over >=4 hours after lactulose consumption
Time Frame
Collected 12 and 24 weeks after enrollment
Title
Change in length-for-age z-score
Description
Difference in length-for-age z-score between enrollment and weeks 12 and 24. Covariate will be baseline LAZ.
Time Frame
Measured 12 and 24 weeks after enrollment
Secondary Outcome Measure Information:
Title
% Lactulose excretion >= 0.2 and >=0.45
Description
Proportion with moderately and severely abnormal small intestinal permeability
Time Frame
Collected 6, 12, and 24 weeks after enrollment
Title
Rate of length gain
Description
mm/week
Time Frame
Across 24 week follow-up period
Title
LAZ < -2
Description
Proportion stunted
Time Frame
Measured 6, 12, 18, and 24 weeks after enrollment
Title
Fecal host mRNA transcripts
Description
CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
Time Frame
Collected 12 and 24 weeks after enrollment
Title
Fecal host proteins MPO, AAT, NEO
Description
Myeloperoxidase, alpha-1 antitrypsin, neopterin
Time Frame
Collected 12 and 24 weeks after enrollment
Title
Rate of weight gain
Description
g/kg/d
Time Frame
Enrollment to week 6, and across 24 week follow-up period
Title
% Lactulose excretion
Time Frame
6 weeks after enrollment
Title
Deterioration to severe acute malnutrition or death
Description
Mid-upper arm circumference < 11.5 cm or nutritional edema
Time Frame
Time-to-event across follow-up period
Title
Recurrence of MAM
Description
MUAC < 12.5 cm
Time Frame
Time-to-event across follow-up period
Title
Sustained recovery
Description
Mid-upper arm circumference >= 12.5 cm without nutritional edema
Time Frame
Weeks 12, 18, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark J Manary, MD
Phone
+1 314-454-2341
Email
manarymj@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bandajuma
City
Bandajuma
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Bendu Maleh
City
Bendu
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Blama Massaquoi
City
Blama Massaquoi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Gbondapi
City
Gbondapi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Gofor
City
Gofor
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Jendema
City
Jendema
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Potoru
City
Potoru
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Pujehun Static
City
Pujehun
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Taninahun
City
Taninahun
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Zimmi
City
Zimmi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Within 12 months of primary publication

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Eggs for Gut Health

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