Probiotic drops may stop antibiotic tummy troubles in children
NCT ID NCT07234448
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests whether a probiotic supplement in oral drops can prevent diarrhea in children aged 0-12 who are taking common antibiotics like amoxicillin. One thousand children will receive either the probiotic or a placebo during their antibiotic course, and researchers will track how many develop diarrhea. The goal is to see if this simple addition to treatment can reduce a frequent and uncomfortable side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bifidobacterium breve PRL2020 probiotic drops
- What this could lead to
- If it works, this could offer a simple, safe way to prevent antibiotic-related diarrhea in children, reducing discomfort and doctor visits.
- What could go wrong
- This is an early-stage trial with no phase designation, so results are uncertain. The probiotic is only given during the antibiotic course, and long-term effects are not studied.
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
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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
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1,100 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Jul 2026
- Lead sponsor
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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
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0 to 12 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male and female participants aged 0-12 years. * Undergoing antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid. * Parent or legal guardian provides written informed consent. Exclusion Criteria: * Use of antibiotic therapy within 4 weeks prior to enrolment. * Use of other probiotic products or lactic acid bacteria during the study. * Pre-existing diarrhea within 4 weeks prior to enrolment. * Chronic inflammatory bowel disease. * Immunodeficiency. * Lack of parental or legal guardian consent to participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Urbino "Carlo Bo"
Urbino, 61029, Italy
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