New probiotic passes first safety test in small human study
NCT ID NCT06380270
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for SAFETY are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new cosmetic pass the skin allergy test?
- Can a new drug pair tame hodgkin lymphoma in older patients?
- Can a new injection shrink advanced solid tumors?
- Can a two-drug combo better tame prostate trouble?
- New vaginal capsule aims to tackle stubborn bacterial vaginosis
- Tiny study checks if novel bacterium is safe for people