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.
Children aged 6 months to 36 months, and
Severe acute malnutrition as evident by weight-for-length z-score (WLZ) < -3 and or mid-upper arm circumference (MUAC) < 11.5 cm, and or edema of both feet, and
Completed the acute phase management for SAM and stayed at NRU for 7±4 days, with no medical complications, e.g. lethargic/unconscious, convulsions, unable to drink, persistent vomiting, respiratory distress.
Residing within the Dhaka district.
WLZ ≥ -3 or MUAC ≥11.5 cm.
Presence of lethargy/unconsciousness, convulsions, unable to drink, persistent vomiting, respiratory distress.
Participants who receive multiple courses of antibiotic (>2 courses during acute phase) treatment for a prolonged period (>14 days).
Persistent diarrhea (≥14 days).
Parallel
Microbiota-directed food
Dietary supplementMDF 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
Dietary supplementKhichuri 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).
Circulating immune cells
Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions
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
Micro biocidal capacity
Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.
Rate of weight gain
Rate of weight gain between the intervention groups over the 12-weeek intervention period.
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Washington University School of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
