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Can a postbiotic soothe diarrhea in vulnerable kids?

NCT ID NCT07758933

Symptom relief Sponsor: Hospital Infantil de Mexico Federico Gomez 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether a postbiotic supplement called Lactobacillus LB (Lactéol®) is safe for hospitalized children under 18 with weakened immune systems who have diarrhea. Participants receive the supplement twice daily for 14 to 28 days alongside standard rehydration and nutrition. The main goal is to monitor for side effects like vomiting, bloating, or allergic reactions, while also exploring whether it helps stop diarrhea and improve stool consistency.

What this could mean

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

Active substance
Lactobacillus LB (Lactéol®), a postbiotic dietary supplement
What this could lead to
If safe, it could offer a gentle, supportive option to help manage diarrhea in vulnerable children with weakened immune systems.
What could go wrong
This is an early-phase, small trial focused on safety, not effectiveness. Risks include allergic reactions, worsening diarrhea, or infections, and results may not apply broadly.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

Up to 18 years

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: 1. Patients under 18 years of age. 2. Patients under hospital care in Federico Gomez Children's Hospital of Mexico 3. Patients with diarrhoea (three or more loose or liquid stools in a 24 hour period, Bristol Stool Scale 5, 6 or 7) and either of two conditions: 1. Immunocompromised patients with diarrhoeal disease within the first 72 hours of initiation 2. Immunocompromised patients with chronic diarrhoea (≥15 days of diarrhoea onset, 4. Patients whose parents or guardians give consent to participate and patients who assent to participate (when applicable) Exclusion Criteria: 1. Non-viable oral or enteral administration of Lactobacillus LB postbiotic (Lactéol®). 2. Bacteriemia or sepsis. 3. Haemodynamic instability. 4. Severe neurological disturbances. 5. Clinical signs of severe dehydration (prolonged capillary refill time, positive skin fold test, abnormal respiratory pattern, or absence of tears). 6. Known intolerance or allergy to intervention components (lactose, fructose, sucrose, silicic acid, banana artificial flavour, orange artificial flavour,). 7. Any exclusion criteria as per investigator assessment.

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Conditions

The condition(s) this trial relates to.

diarrheal disease

As listed by the trial registrant

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

Diarrhea

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

    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

    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

  • Hospital Infantil de Mexico Federico Gomez

    Cuahutemoc, Mexico City, 06720, Mexico

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