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Can a new food blend help heal the gut of malnourished children?

NCT ID NCT07804667

Disease control Sponsor: Wuqu' Kawoq, Maya Health Alliance 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This pilot study tests whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. Researchers compare the new supplement with Nutri Listo, a standard lipid-based nutrient supplement already used in the country. Children are randomly assigned to receive one 30-gram sachet daily for 21 days. The study measures how much children eat, any stomach or bowel symptoms, and changes in stool markers related to gut inflammation and microbial activity.

What this could mean

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

Active substance
A modified therapeutic food supplement containing green banana flour, chickpea flour, peanut paste, and other nutrients, given as a daily 30-gram sachet for 21 days.
What this could lead to
If this food supplement is well accepted and shows signs of improving gut health, it could point toward a new way to help children with chronic malnutrition and stunting.
What could go wrong
This is a small pilot study, so it cannot prove the supplement improves growth. It only looks at short-term gut markers, and children may not like the taste or may have stomach issues.

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 36 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

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

12 to 24 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 12 to 24 months at enrollment * Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3 * Primary caregiver willing and able to provide informed consent * Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication Exclusion Criteria: * Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2 * Antibiotic use within the preceding 14 days * Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg * History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month * Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods

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As listed by the trial registrant

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

Chronic malnutrition Stunting of growth

How to take part

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  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Centro Comunitario de Salud Chuti Estancia

    San Andrés Semetabaj, Departamento de Sololá, Guatemala

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