Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

August 23, 2026 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Dhaka Division
      • Dhaka, Dhaka Division, Bangladesh, 1212
        • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Microbiota-directed food
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
Active Comparator: Khichuri
Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.
Dietary supplement: Khichuri
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks
Micro biocidal capacity
Time Frame: 12 weeks
Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.
12 weeks
Rate of weight gain
Time Frame: 12 weeks
Rate of weight gain between the intervention groups over the 12-weeek intervention period.
12 weeks
Diarrhea and pneumonia
Time Frame: 12 weeks
Incidence of acute diarrhea and pneumonia during the study period.
12 weeks
Gut microbiota
Time Frame: 12 weeks
Composition and evolution of gut microbiota over the 12-weeek intervention period.
12 weeks
Case fatality rate
Time Frame: 12 weeks
Case fatality rate within 12 weeks post discharge.
12 weeks
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Washington University School of Medicine

Investigators

  • Principal Investigator: Farzana Afroze, MBBS, FCPS, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 23, 2026

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-24010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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