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Completed

NCT Number: NCT06530485

Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

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.

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Key information

Conditions

Child Malnutrition Child Nutrition Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Dhaka Division, 1212, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microbiota-Directed Food

Dietary Supplement

MDF can modulate the gut microbiota and enhance host immunity, growth, and development in malnourished children. Each sachet of MDF (100 gm) provides approximately 500 kcal.

Other names: MDF

Khichuri

Dietary Supplement

Khichuri is a home-based nutritious food with high energy and protein. This arm also contains zinc (10 gm/day), micronutrient powder, and an egg daily.

Other names: Locally available food

Primary outcomes

  1. NK cells

    Time frame: 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 outcomes

  1. Circulating immune cells

    Time frame: 12 weeks

    Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions

  2. Rate of weight gain

    Time frame: 12 weeks

    Rate of weight gain between the intervention groups over the 12-weeek intervention period.

  3. Cytokines and chemokines

    Time frame: 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

  4. Micro biocidal capacity

    Time frame: 12 weeks

    Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.

  5. Diarrhea and pneumonia

    Time frame: 12 weeks

    Incidence of acute diarrhea and pneumonia during the study period.

  6. Gut microbiota

    Time frame: 12 weeks

    Composition and evolution of gut microbiota over the 12-weeek intervention period.

  7. Case fatality rate

    Time frame: 12 weeks

    Case fatality rate within 12 weeks post discharge.

  8. Anthropometric recovery

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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