An interventional study of Microbiota-directed food and Khichuri in Child Malnutrition, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Supportive care
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:
164 studies on the registry are indexed under Child Nutrition Disorders; 34 are open to participants now.
This study's enrollment of 154 is below the median of 428 across 130 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 197 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children randomized to this group will receive Microbiota-directed food (MDF) daily for 12 weeks. MDF can modulate the gut microbiota and enhance host immunity, growth, and development in malnourished children.
Dietary Supplement: Microbiota-directed food
Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.
Dietary Supplement: Khichuri
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.
Also known as: MDF
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.
Also known as: Locally available food
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
Rate of weight gain
Rate of weight gain between the intervention groups over the 12-weeek intervention period.
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh