Clinical trial NCT06530485: Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
Official title: Enhancing Immunity and Nutrition in Severely Malnourished Children Following Hospital Discharge: a Two Arm Open-label Randomized Controlled Trial of Microbiota-Directed Food vs. Zinc With Micronutrient Powder and Khichuri
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Malnutrition
Keywords: Immunity
Malnutrition
Microbiota-directed food (MDF)
Zinc
NK cells
Gut microbiota
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2024-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: NK cells
timeFrame: 12 weeks
Secondary outcomes:
measure: Circulating immune cells
timeFrame: 12 weeks
measure: Cytokines and chemokines
timeFrame: 12 weeks
measure: Micro biocidal capacity
timeFrame: 12 weeks
measure: Rate of weight gain
timeFrame: 12 weeks
measure: Diarrhea and pneumonia
timeFrame: 12 weeks
measure: Gut microbiota
timeFrame: 12 weeks
measure: Case fatality rate
timeFrame: 12 weeks
measure: Anthropometric recovery
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Farzana Afroze
role: PRINCIPAL_INVESTIGATOR
References: