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Dead probiotic bacteria put to the test in Kids' saliva

NCT ID NCT07825324

Prevention Sponsor: Jagiellonian University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers at Jagiellonian University are testing whether chewable tablets containing heat-inactivated Lactobacillus salivarius HM-6 Paradens can change saliva pH and immune markers in preschool children. Seventy-two healthy children aged 3 to 6 take two tablets daily for 14 days, one after breakfast and one at bedtime. The team collects saliva before and after the intervention to measure pH, secretory IgA, and human beta-defensin 2. The goal is to see if this short, non-invasive routine can support the oral environment in young children.

What this could mean

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

Active substance
chewable tablets containing heat-inactivated Lactobacillus salivarius HM-6 Paradens
What this could lead to
If the tablets shift saliva pH or immune markers, this could point toward a simple, non-invasive way to support young children's oral health.
What could go wrong
The study is small and short, and it measures saliva markers rather than cavities, so any changes may not translate into real dental benefits. The tablets are heat-inactivated, meaning the bacteria are dead, which may limit their effect.

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

72 people

The number who actually took part.

Started

Sep 2018

Finished

Jan 2019

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 6 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: * age 3-6 years; * generally good health; * no use of antibiotics or probiotics in the three months preceding study entry; * ability and willingness of the child to chew tablets and participate in study pro-cedures; * obtaining written informed consent from a parent or legal guardian. Exclusion Criteria: * severe infections, systemic diseases, immune disorders, congenital defects * food allergies * active inflammatory diseases of the oral cavity, periodontal disease, and the presence of fixed orthodontic appliances * the use of anti-inflammatory medications, glucocorticosteroids, probiotics, vitamin supplements, or other products that could affect the parameters assessed within three months of the study * partial or complete refusal of a dental examination by the child or their guardian

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As listed by the trial registrant

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

Probiotic

Contacts and locations

Locations

  • Jagiellonian University Medical College in Krakow

    Krakow, Małoposlka, 31-155, Poland

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