Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

Not Applicable

Not yet recruiting

• Conditions: Child Malnutrition
• Interventions: Dietary Supplement: Khichuri; Dietary Supplement: Microbiota-directed food

• Registration Number: NCT06530485
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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, 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study Start: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Khichuri	Khichuri	Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.
Microbiota-directed food	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.

Primary Outcome Measures

Name	Time	Method
NK cells	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Anthropometric recovery	12 weeks	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).
Circulating immune cells	12 weeks	Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions
Cytokines and chemokines	12 weeks	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
Diarrhea and pneumonia	12 weeks	Incidence of acute diarrhea and pneumonia during the study period.
Micro biocidal capacity	12 weeks	Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.
Case fatality rate	12 weeks	Case fatality rate within 12 weeks post discharge.
Rate of weight gain	12 weeks	Rate of weight gain between the intervention groups over the 12-weeek intervention period.
Gut microbiota	12 weeks	Composition and evolution of gut microbiota over the 12-weeek intervention period.