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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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 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.
NK cells
Differences in the proportion and activity of circulating NK cells between the groups 12 weeks after the intervention, measured by flow cytometry/fluorescence-assisted cell sorter (FACS).
Time frame: 12 weeks
Circulating immune cells
Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions
Time frame: 12 weeks
Cytokines and chemokines
Differences in the levels of pro-inflammatory and anti-inflammatory cytokines and chemokines in circulation, which can provide insights into the functional status of immune cells
Time frame: 12 weeks
Micro biocidal capacity
Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.
Time frame: 12 weeks
Rate of weight gain
Rate of weight gain between the intervention groups over the 12-weeek intervention period.
Time frame: 12 weeks
Diarrhea and pneumonia
Incidence of acute diarrhea and pneumonia during the study period.
Time frame: 12 weeks
Gut microbiota
Composition and evolution of gut microbiota over the 12-weeek intervention period.
Time frame: 12 weeks
Case fatality rate
Case fatality rate within 12 weeks post discharge.
Time frame: 12 weeks
Anthropometric recovery
Anthropometric recovery from SAM: anthropometric recovery will be defined as reaching a WLZ of \>-2 (for those admitted with WLZ \<-2) and or MUAC \>12.5 (for those admitted with MUAC \<12.5 cm).
Time frame: 12 weeks
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