Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
NCT ID: NCT06530485
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-08-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Microbiota-directed food
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.
Microbiota-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.
Khichuri
Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.
Khichuri
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.
Interventions
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Microbiota-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.
Khichuri
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
36 Months
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Responsible Party
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Principal Investigators
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Farzana Afroze
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Contacts
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Other Identifiers
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PR-24010
Identifier Type: -
Identifier Source: org_study_id
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