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Can a probiotic stop bloody diarrhea in kids faster?

NCT ID NCT07371819

Symptom relief Sponsor: Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Saccharomyces boulardii can help children aged 3 months to 5 years recover faster from bloody diarrhea. About 140 children will receive either the probiotic or a placebo, and researchers will track how long the bloody diarrhea lasts and how many bloody stools occur each day. The goal is to see if this probiotic is a safe and effective treatment for this severe form of diarrhea.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 140 people

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

Started

Jan 2019

Expected to finish

Feb 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

3 to 71 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: * all children between 0.25 and 5.99 years * attending emergency clinic because of acute diarrhea, * showing stools with presence of blood, * whose parents were adequately informed, and signed the corresponding consent Exclusion Criteria: * diarrhea lasting more than 7 days at inclusion * presence of malnutrition and any other chronic or major disease, * previous or concomitant intake of steroids, or other immunosuppressive drugs, * immunocompromised

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Conditions

The condition(s) this trial relates to.

dysentery

As listed by the trial registrant

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

Acute bloody diarrhea of 7 days or less duration

Contacts and locations

Locations

  • Hospital Materno Infantil de Salta

    Salta, Salta Province, 4400, Argentina

  • Hospital Ramos Mejía, Servicio de Pediatría (SPHRM)

    Buenos Aires, Buenos Aires F.D., 1704, Argentina

  • Hospital Tetamanti in Mar del Plata (HIEMI)

    Mar del Plata, Buenos Aires, 7600, Argentina