Study to Evaluate the Safety and Human Tolerance of the Oral Probiotic Streptococcus Salivarius eK12: A Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Effect on other physical features
研究概览
简要总结
The human oral cavity contains a diverse community of microorganisms essential for oral and overall health. Streptococcus salivarius K12 (eK12) has emerged as a promising oral probiotic due to its natural colonization of the throat and its ability to inhibit pathogens such as Streptococcus pyogenes, a major cause of streptococcal pharyngitis. It supports oral hygiene by producing antimicrobial substances like salivaricins and inhibiting odor-causing bacteria. The engineered eK12 variant (Bactoblis® Evol) has been developed to overcome inactivation by GAS-secreted protease SpeB, thereby enhancing its prophylactic potential against Group A Streptococcus (GAS) colonization.
This clinical study includes a randomized, double-blind, placebo-controlled trial in Pakistan to evaluate the safety and human tolerance of eK12 in healthy adults. To enhance generalizability, an additional open-label cohort of healthy adults in Italy will receive eK12 without a control group.
详细描述
The aim of the present clinical study is to evaluate the safety and tolerability of Streptococcus salivarius eK12 in healthy adults. The study consists of a randomized, double-blind, placebo-controlled arm in Pakistan involving 29 participants (allocated 1:1 to eK12 or placebo).
In addition, an open-label cohort of 20 healthy adults will be enrolled in Italy, all of whom will receive eK12, to assess tolerability in a separate population without a control group. This complementary cohort is included to enhance the generalizability of the findings across different populations and to obtain supportive safety data in a real-world setting where the product (commercially available in the EU as Bactoblis® Evol) is already in use.
Through comprehensive assessments and close monitoring of participants, this study will provide critical insights into the safety profile and human tolerance of the probiotic-modified strain. The findings will contribute to the growing body of knowledge needed to support its use in oral health management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Effect on other physical features
时间窗: 3-months
Incidence of any physical abnormality in the skin, eyes, ears, nose, throat, and mental health
Effect on blood electrolytes balance
时间窗: 3-months
Electrolyte tests (e.g., sodium, potassium, chloride, bicarbonate)
Incidence of inflammation
时间窗: 3-months
C-recative protein (CRP) blood test
Effect on oral health physical condition
时间窗: 3-months
Incidence of physical abnormality in pharynx, tongue, teeth, gums and oral mucosa
Effect on hematology
时间窗: 3-months
Full blood count
Incidence of gastrointestinal side effects
时间窗: 3-months
Abdominal pain, bloating, gastric reflux, nausea, vomiting, diarrhea, and gas or flatulence
Incidence of Adverse events (AEs)
时间窗: 3-months
Any adverse events that may occur during the study period
Effect on vital signs
时间窗: 3-months
Any changes in the heart rate (heart beats per minute (bpm))
Effect on blood biochemistry
时间窗: 3-months
Any changes in the liver function tests (Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase)
次要结局
未报告次要终点
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences