Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Microbiota-directed food
  • Khichuri

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Lead sponsor

Washington University School of Medicine

Collaborator