Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different types of food can help boost the immune systems of severely malnourished children after they recover from a serious infection. The researchers want to find out if a special type of food, called microbiota-directed food (MDF), is more effective in improving immunity compared to zinc mixed with micronutrients and a traditional dish called Khichuri. The children involved in the study will be given either the MDF or the zinc and micronutrient mixture along with Khichuri every day for 12 weeks. The researchers will then examine the children's immune cells to see how well their bodies are responding.

To participate in this trial, children must be between 6 months and 36 months old and show signs of severe malnutrition, such as being very underweight or having swelling in their feet. They should have recently completed treatment for malnutrition and be living in the Dhaka district. Parents or guardians will need to give their written permission for their child to join the study. Children who have other serious health issues, have been treated for malnutrition recently, or have certain food allergies will not be eligible. This trial is not yet recruiting participants, but it aims to help improve the health and immunity of malnourished children in the future.

Gender

ALL

Eligibility criteria

• 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.