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Can a new formula save more children from severe malnutrition?

NCT ID NCT07752628

Disease control Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether an enhanced therapeutic formula, F-60, is as safe as the current standard F-75 for children hospitalized with severe acute malnutrition. The study will compare safety and early recovery outcomes in 320 children aged 6 to 59 months. If F-60 is safe and effective, it could improve survival and reduce complications in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
F-60 milk feed, an enhanced nutrient-fortified therapeutic formula
What this could lead to
If F-60 proves safe and effective, it could offer a better stabilization formula for severely malnourished children, potentially reducing complications and deaths in low-resource settings.
What could go wrong
This is a safety trial, so it may not show clear benefits. The formula might not be as effective as hoped, and there are risks like refeeding syndrome and other complications in these fragile children.

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

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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 59 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: * Age 6 to 59 months. * Severe Acute Malnutrition (WHZ \<-3 z-scores of the median WHO growth standards and/or MUAC \<11.5 cm or bilateral pitting nutritional edema). * Received a maximum of 2 feeds of F75 (or milk suzi) at the time of enrolment. * Primary caregiver is able to provide written or witnessed informed consent. Exclusion Criteria: * Congenital heart disease * A known or suspected diagnosis of tuberculosis at the time of screening * Anatomic abnormalities of the gastrointestinal tract * Cancer * Spastic cerebral palsy, hydrocephalus, * Haemoglobinopathies. * Children weigh more than 16 kg * Diarrhea lasting more than 14 days prior to hospitalization. * Children who require invasive critical care (ie, mechanical ventilation, continuous positive airway pressure (CPAP) \>5 cm H2O, or \>1 inotrope for BP support) will be ineligible. Informed written consent will be obtained from the child's guardian, following local practices.

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Conditions

The condition(s) this trial relates to.

Malnutrition nutritional deficiency disease Severe Acute Malnutrition

As listed by the trial registrant

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

Children Dietary supplementation Severe acute malnutrition

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icddr,B

    Dhaka, 1212, Bangladesh

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