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New probiotic passes first safety test in small human study

NCT ID NCT06380270

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study tested whether an oral probiotic called Streptococcus salivarius eK12 is safe and well-tolerated in healthy adults. Researchers gave 29 participants either the probiotic or a placebo and monitored for side effects, changes in vital signs, and blood test results. The goal was to see if this probiotic could eventually be used to support oral health and prevent infections like strep throat.

What this could mean

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

Active substance
Oral probiotic Streptococcus salivarius eK12 (Bactoblis® Evol)
What this could lead to
If successful, this could confirm that the probiotic is safe for people, paving the way for larger studies on preventing strep throat or improving oral hygiene.
What could go wrong
This is a small, early-stage safety study with only 29 participants, so it cannot prove the probiotic works for any condition. Side effects like stomach upset are possible.

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

29 people

The number who actually took part.

Started

Nov 2024

Finished

Aug 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

18 to 60 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: * Adults, both male and female, aged 18 to 60 years. * Stable health condition with no acute illness at the time of enrollment. * BMI 18.5-35 kg/m2 * No known food allergies or intolerances to probiotics * All clinical chemistry, hematology and urinalysis parameters and vital signs (blood pressure, respiratory rate, temperature, heart rate) within clinically acceptable ranges. * Ability and willingness to provide informed consent. * Must be willing to comply with study procedures and attend scheduled visits. Exclusion Criteria: * Individuals with a history of severe allergies or adverse reactions to probiotics or any of the components of the study product. * Participants with a recent history of oral surgery or dental procedures within the past 4 weeks. * Individuals with severe dental problems or undergoing active dental treatment. * Individuals with a known diagnosis of systemic diseases affecting the oral cavity (e.g., oral cancer, Sjögren's syndrome). * Individuals with compromised immune systems, or a history of immunodeficiency disorders or undergoing immunosuppressive therapy. * Pregnant or breastfeeding females. * Current smokers or individuals who have quit smoking within the past 6 months. * Individuals currently using antibiotics or have used them within the past 4 weeks. * Individuals with a history of gastrointestinal disorders (e.g., inflammatory bowel disease, irritable bowel syndrome). * Individuals with unstable metabolic diseases/disorders, heart failure or a history of endocarditis. * Frequent user of alcohol or over the counter laxatives, or herbal-based supplements (but not vitamin supplements), or prescription drugs that may potentially influence the biomarkers to be measured in the study. * Those with any chronic systemic illness that might affect participation in the trial or interpretation of results. * Participants currently enrolled in another clinical trial involving probiotics or oral health interventions. * Those unable to adhere to the study protocol or unlikely to complete the study period due to anticipated relocation or other personal reasons. * Any other condition or circumstances that, in the opinion of the investigator, might compromise the safety of the participant or the validity of the study results.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Jam Ghulam Qadir Civil Hospital

    Hub, 90250, Pakistan

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