Evaluation of Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius eK12

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 (bloodpressure, respiratory rate, temperature, heart rate) within clinically acceptableranges.

• 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 orany of the components of the study product.

• Participants with a recent history of oral surgery or dental procedures within thepast 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 immunodeficiencydisorders 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 boweldisease, irritable bowel syndrome).

• Individuals with unstable metabolic diseases/disorders, heart failure or a historyof endocarditis.

• Frequent user of alcohol or over the counter laxatives, or herbal-based supplements (but not vitamin supplements), or prescription drugs that may potentially influencethe biomarkers to be measured in the study.

• Those with any chronic systemic illness that might affect participation in the trialor interpretation of results.

• Participants currently enrolled in another clinical trial involving probiotics ororal health interventions.

• Those unable to adhere to the study protocol or unlikely to complete the studyperiod due to anticipated relocation or other personal reasons.

• Any other condition or circumstances that, in the opinion of the investigator, mightcompromise the safety of the participant or the validity of the study results.