Could a Microbiota-Targeted food strengthen immunity in malnourished kids?
NCT ID NCT06530485
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial tests whether a microbiota-directed food (MDF) can enhance immunity in severely malnourished children better than standard zinc with micronutrient powder and khichuri. Children aged 6-36 months who have recovered from acute infection will receive either MDF or the standard supplement daily for 12 weeks. Researchers will measure changes in immune cells like NK cells, T cells, and B cells to see if MDF improves immune function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Microbiota-directed food (MDF) compared to zinc with micronutrient powder and khichuri
- What this could lead to
- If MDF works, it could offer a better way to help severely malnourished children recover stronger immunity after hospital discharge.
- What could go wrong
- This is a small, early-stage trial, so results may not apply broadly. The food supplement may not significantly improve immune markers compared to standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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154 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 36 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Dhaka Division, 1212, Bangladesh
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