Child Malnutrition
Conditions
Keywords
Immunity, Malnutrition, Microbiota-directed food (MDF), Zinc, NK cells, Gut microbiota
Brief 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.
Interventions
DIETARY_SUPPLEMENTMicrobiota-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.
DIETARY_SUPPLEMENTKhichuri
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.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* 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. * Parents/guardians provided written informed consent.
Exclusion criteria
* 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). * Chronic illness or disability affecting food intake, e.g. TB, HIV, congenital defects, cerebral palsy * Treated for SAM in the previous 3 months. * Known case of soy, peanut, or milk protein allergy. * Any sibling of the enrolled child.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NK cells | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating immune cells | 12 weeks | Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions |
| Rate of weight gain | 12 weeks | Rate of weight gain between the intervention groups over the 12-weeek intervention period. |
| Cytokines and chemokines | 12 weeks | 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 | 12 weeks | Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes. |
| Diarrhea and pneumonia | 12 weeks | Incidence of acute diarrhea and pneumonia during the study period. |
| Gut microbiota | 12 weeks | Composition and evolution of gut microbiota over the 12-weeek intervention period. |
| Case fatality rate | 12 weeks | Case fatality rate within 12 weeks post discharge. |
| Anthropometric recovery | 12 weeks | 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). |
Countries
Bangladesh
Contacts
PRINCIPAL_INVESTIGATORFarzana Afroze, MBBS, FCPS
International Centre for Diarrhoeal Disease Research, Bangladesh
Outcome results
None listed