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Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Summary
The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells (monocytes, T cells, B cells, and NK cells) in malnourished children after recovery from acute infection. The study aims to answer the research question: Does microbiota-directed food (MDF) compared to zinc with micronutrient powder (MNP) and Khichuri therapy enhance immunity in children with severe acute malnutrition? The researcher will compare the effectiveness of microbiota-directed food (MDF) versus zinc with micronutrient powder (MNP) and Khichuri therapy to see if MDF enhances immunity in severely malnourished children. Severely malnourished children will: * Receive microbiota-directed food (MDF) or zinc with micronutrient powder (MNP) and Khichuri every day for 12 weeks. * Phenotyping of circulating immune cells (NK cells, T cells, B cells) will be conducted using flow cytometry and fluorescence-activated cell sorting techniques.
Official title: Enhancing Immunity and Nutrition in Severely Malnourished Children Following Hospital Discharge: a Two Arm Open-label Randomized Controlled Trial of Microbiota-Directed Food vs. Zinc With Micronutrient Powder and Khichuri
Key Details
Gender
All
Age Range
6 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-08-01
Completion Date
2025-12-31
Last Updated
2024-08-02
Healthy Volunteers
No
Conditions
Interventions
Microbiota-directed food
MDF can modulate the gut microbiota and enhance host immunity, growth, and development in malnourished children. Each sachet of MDF (100 gm) provides approximately 500 kcal.
Khichuri
Khichuri is a home-based nutritious food with high energy and protein. This arm also contains zinc (10 gm/day), micronutrient powder, and an egg daily.