Could a Microbiota-Targeted food strengthen immunity in malnourished kids?

NCT ID NCT06530485

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

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

154 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

Lead sponsor

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

6 to 36 months

Sex

Anyone

Healthy volunteers

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

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.

Child Nutrition Disorders Malnutrition nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka, Dhaka Division, 1212, Bangladesh

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