Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

International Centre for Diarrhoeal Disease Research (icddr,b)

Status: Not yet enrolling

Conditions: Child Malnutrition

Treatments: Dietary Supplement: Microbiota-directed food; Dietary Supplement: Khichuri

Study type: Interventional

Funder types: Other

Identifiers

NCT06530485

PR-24010

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Microbiota-directed food

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Microbiota-directed food

Khichuri

Active Comparator group

Description:

Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.

Treatment:

Dietary Supplement: Khichuri