Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbiota-directed food | Experimental | 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. |
|
| Khichuri | Active Comparator | Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiota-directed food | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating immune cells | Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farzana Afroze, MBBS, FCPS | Contact | +8801722363067 | farzana9afroze9@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Farzana Afroze | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C074705 | milk-derived factor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Khichuri | Dietary Supplement | 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. |
|
|
| 12 weeks |
| Micro biocidal capacity | Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes. | 12 weeks |
| Rate of weight gain | Rate of weight gain between the intervention groups over the 12-weeek intervention period. | 12 weeks |
| Diarrhea and pneumonia | Incidence of acute diarrhea and pneumonia during the study period. | 12 weeks |
| Gut microbiota | Composition and evolution of gut microbiota over the 12-weeek intervention period. | 12 weeks |
| Case fatality rate | Case fatality rate within 12 weeks post discharge. | 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). | 12 weeks |