Status:
NOT_YET_RECRUITING
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Child Malnutrition
Eligibility:
All Genders
6-36 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06530485
Start Date
August 1 2024
End Date
December 31 2025
Last Update
August 2 2024
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