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Can a probiotic shield kids from antibiotic side effects?

NCT ID NCT07015736

Disease control Sponsor: Eskisehir Osmangazi University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study tests whether giving a probiotic (Saccharomyces boulardii) along with a common antibiotic can protect the gut bacteria of children aged 4 to 12 being treated for ear or sinus infections. The goal is to see if it reduces antibiotic-associated diarrhea and limits the spread of antibiotic-resistant genes. One hundred children will receive either the antibiotic alone or with the probiotic for 10 to 21 days.

What this could mean

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

Active substance
Saccharomyces boulardii CNCM I-745 (a probiotic yeast)
What this could lead to
If it works, this could show that taking a probiotic alongside antibiotics helps prevent diarrhea and keeps the gut microbiome healthy in children.
What could go wrong
This is a small, early-phase study with only 100 children, so results may not apply to everyone. The probiotic might not reduce diarrhea or could cause side effects like bloating.

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

100 people

The number who actually took part.

Started

Aug 2025

Finished

Sep 2026

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

4 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Diagnosed with acute otitis medica or acute rhinosinusitis No chronic diseases or recent antibiotic/probiotic use (past 8 weeks) Parental consent obtained Exclusion Criteria: Age \<4 or \>12 years Chronic illness or GI disorders History of antibiotic allergy or immunocompromise Malnutrition or obesity Recent gastrointestinal surgery

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis infectious otitis media otitis media sinusitis

As listed by the trial registrant

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

Acute otitis media Acute sinusitis Antibiotic associated diarrhea

Contacts and locations

Locations

  • Acibadem Univsersity Faculty of Medicine

    Istanbul, Turkey (Türkiye)

  • Eskisehir Osmangazi University

    Eskişehir, 26040, Turkey (Türkiye)

  • Sancaktepe Şehit Prof.Dr. İlhan Varank Training and Research Hospital

    Istanbul, Turkey (Türkiye)

  • Şişli Hamidiye Etfal Training and Research Hospital

    Istanbul, Turkey (Türkiye)

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