Child MalnutritionNCT06530485
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
A study testing Microbiota-directed food and Khichuri in people with Child Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Microbiota-directed food and Khichuri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Dhaka Division, 1212
About this study
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
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:
Read more
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
- Being tested
- Microbiota-directed food, Khichuri
- Keywords
- Immunity, Malnutrition, Microbiota-directed food (MDF), Zinc, NK cells, Gut microbiota
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota-directed foodDietary supplement
Also called MDF
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.
KhichuriDietary supplement
Also called Locally available food
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Khichuri |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (8)
Circulating immune cells
Differences in the proportion of circulating immune cells (NK cells, T cells, B cells) before and after the interventions
Measured: 12 weeks
Rate of weight gain
Rate of weight gain between the intervention groups over the 12-weeek intervention period.
Measured: 12 weeks
Cytokines and chemokines
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
Measured: 12 weeks
Micro biocidal capacity
Differences in the micro biocidal capacity (oxidative burst) of neutrophils and monocytes.
Measured: 12 weeks
Diarrhea and pneumonia
Incidence of acute diarrhea and pneumonia during the study period.
Measured: 12 weeks
Gut microbiota
Composition and evolution of gut microbiota over the 12-weeek intervention period.
Measured: 12 weeks
Case fatality rate
Case fatality rate within 12 weeks post discharge.
Measured: 12 weeks
Anthropometric recovery
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farzana Afroze, MBBS, FCPS, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530485
- Sponsor's protocol ID
- PR-24010
- Status last verified
- Sep 2024
- First submitted
- 28 Jul 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06530485
- Acronym / sponsor ID
- PR-24010
- Conditions
- Child Malnutrition
- Keywords
- Immunity, Malnutrition, Microbiota-directed food (MDF), Zinc, NK cells, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbiota-directed food | Experimental | Dietary Supplement: Microbiota-directed foodChildren 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. |
| Khichuri | Active comparator | Dietary Supplement: KhichuriChildren randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota-directed foodAlso: MDFMDF 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. | Dietary supplement | Microbiota-directed food |
| KhichuriAlso: Locally available foodKhichuri 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. | Dietary supplement | Khichuri |
Primary outcome
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).
8 secondary outcomes
Circulating immune cells
Time frame: 12 weeks
Rate of weight gain
Time frame: 12 weeks
Cytokines and chemokines
Time frame: 12 weeks
Micro biocidal capacity
Time frame: 12 weeks
Diarrhea and pneumonia
Time frame: 12 weeks
Gut microbiota
Time frame: 12 weeks
Case fatality rate
Time frame: 12 weeks
Anthropometric recovery
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzana Afroze, MBBS, FCPS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiota-directed food and Khichuri in people with Child Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NK cells (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.