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Can a probiotic shield Kids' guts from antibiotic diarrhea?

NCT ID NCT07785206

Prevention Sponsor: University of Child Health Sciences and Children's Hospital, Lahore 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether giving children a probiotic called Saccharomyces boulardii alongside a common antibiotic can prevent diarrhea, a frequent side effect. Children aged 6 months to 5 years with upper respiratory infections will receive either the antibiotic alone or the antibiotic plus the probiotic for 5 days. The study tracks how many children develop diarrhea during treatment and for two weeks after, to see if the probiotic offers protection.

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, a probiotic supplement, given alongside the antibiotic co-amoxiclav
What this could lead to
If effective, adding this probiotic to antibiotic treatment could become a simple, safe way to prevent a common side effect in children.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. The probiotic might not reduce diarrhea risk, and individual responses can vary.

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 88 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

May 2027

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

6 months to 5 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 6 months to 5 years presenting with upper respiratory tract infection (URTI) * Prescribed standard oral co-amoxiclav therapy * Both male and female patients * Written informed consent provided by parents or legal guardians Exclusion Criteria: * Presence of diarrhea at the time of study enrollment * Prior use of probiotics during the current course of illness * Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment * Concomitant use of other medications * Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii * Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy * History of chronic diarrhea * Presence of 3rd degree (severe) malnutrition * Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis respiratory tract infectious disorder

As listed by the trial registrant

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

Antibiotic associated diarrhea Upper respiratory tract infection

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

  • University of Child Health sciences, Children's hospital,Lahore

    Lahore, Punjab Province, Pakistan

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