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Probiotic shows promise in easing antibiotic side effects in kids

NCT ID NCT05840588

Symptom relief Sponsor: Liaquat University of Medical & Health Sciences 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a probiotic called Bifidobacterium breve PRL2020 could reduce stomach issues like diarrhea in 121 children aged 3-12 who were taking amoxicillin antibiotics. The children took the probiotic alongside their antibiotic treatment. The goal was to see if it helped maintain healthy gut bacteria and eased symptoms.

What this could mean

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

Active substance
Probiotic Bifidobacterium breve PRL2020 (Brevicillin®)
What this could lead to
If it works, this could offer a simple way to reduce stomach problems like diarrhea in children taking common antibiotics.
What could go wrong
This is a small, completed study with 121 children, and the results may not apply to all kids or antibiotics. The probiotic might not work for everyone.

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

121 people

The number who actually took part.

Started

Nov 2023

Finished

Apr 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

3 to 12 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: * Children aged between 3-12 years, of either gender, with a bacterial infection and the use of antibiotic therapy with Amoxicillin or Amoxicillin/clavulanic acid under a Physician's prescription. Exclusion Criteria: * Presence of neurological, oncological (also past), malformative, and/or autoimmune pathology * Suspected or presumed allergy to the substance contained in the probiotic formula * Using any type of probiotic product in the three months before the enrollment or during the trial * Lack of parental consent to participate in the study

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease

As listed by the trial registrant

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

Bacterial infections

Contacts and locations

Locations

  • Università di Urbino Carlo Bo

    Urbino, PU (Pesaro E Urbino), 61029, Italy

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