About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Microbiota-directed food
- Khichuri
Treatment groups
Locations
Sponsors and collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Washington University School of Medicine
Collaborator