Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

NCT06530485 | Not Yet Recruiting DMC

• 1 other identifier: PR-24010
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Malnutrition

Keywords

Immunity; Malnutrition; Microbiota-directed food (MDF); Zinc; NK cells; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• NK cells

  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).

  12 weeks

Secondary Outcomes (8)

• Circulating immune cells

  12 weeks

• Cytokines and chemokines

  12 weeks

• Micro biocidal capacity

  12 weeks

• Rate of weight gain

  12 weeks

• Diarrhea and pneumonia

  12 weeks

Study Arms (2)

Microbiota-directed food

EXPERIMENTAL

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.

Dietary Supplement: Microbiota-directed food

Khichuri

ACTIVE COMPARATOR

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

Dietary Supplement: Khichuri

Interventions

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.

Also known as: MDF

Microbiota-directed food

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.

Also known as: Locally available food

Khichuri

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Washington University School of Medicine: collaborator

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Interventions

milk-derived factor

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Farzana Afroze

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farzana Afroze, MBBS, FCPS

CONTACT

+8801722363067; farzana9afroze9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share