Antibacterial Efficacy of a Probiotic Containing L. Salivarius: in Vivo Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in salivary pH
研究概览
简要总结
This study aims to evaluate whether a short, 14-day administration of chewable tablets containing heat-inactivated Lactobacillus salivarius HM-6 Paradens can influence selected salivary parameters related to oral health in preschool children. The probiotic preparation used in the intervention group is a commercially available product (Acidolac Dentifix Kids, Polpharma, Poland). Each tablet contains 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens, along with isomalt, sucralose, natural strawberry flavor, magnesium stearate, and 200 mg of xylitol.
Children in the intervention group receive two chewable tablets per day for 14 consecutive days: one after breakfast and one at bedtime. Each tablet is taken after toothbrushing. After chewing the tablet, children are instructed not to eat or drink for two hours to ensure consistent exposure to the preparation. Adherence is monitored by counting unused tablets returned by caregivers. Missing no more than two tablets per week is considered acceptable adherence, while more frequent missed doses are classified as questionable compliance. Caregivers are asked to report any illnesses, adverse events, or circumstances that may influence the child's participation.
Before the intervention, each child undergoes a dental examination. The presence of early childhood caries (ECC) is recorded, and caries severity is assessed using the International Caries Detection and Assessment System II (ICDAS II). Baseline ICDAS II scores are used to analyze whether initial caries severity affects changes in salivary parameters.
Saliva samples are collected at two time points: before the intervention and after 14 days of follow-up. Collections take place between 8:00 AM and 10:00 AM. Caregivers ensure that children do not eat or drink (except water) for at least 60 minutes before sampling and do not perform oral hygiene beforehand. Unstimulated whole saliva is collected into sterile polypropylene tubes, refrigerated immediately, centrifuged to remove debris, aliquoted, and stored at -80°C. Stimulated saliva is collected using a Salivette kit (Sarstedt, Germany). Children chew a sterile swab for 2-3 minutes, after which the sample is centrifuged, aliquoted, and stored at -80°C. All samples undergo one freeze-thaw cycle before analysis.
Salivary pH is measured at baseline and after the intervention under standardized preanalytical conditions. Results are reported as dimensionless pH values.
The study procedures are non-invasive and well tolerated by children. The goal is to determine whether short-term exposure to an inactivated probiotic preparation can beneficially influence the oral environment and salivary biomarkers in preschool-aged children.
详细描述
The study was a prospective, randomized, controlled trial with two parallel groups. It was conducted at the Department of Developmental Dentistry, Institute of Dentistry, Jagiellonian University Medical College in Krakow. The study protocol was implemented in accordance with the principles of the Declaration of Helsinki and the CONSORT recommendations. Approval for the study was obtained from the Bioethics Committee of the Jagiellonian University in Krakow, No. 1072.6120.31.2018.
Eighty generally healthy children aged 3-6 years, with or without clinical signs of early childhood caries (ECC), were enrolled in the screening study. Eight children were excluded due to failure to meet the inclusion criteria. Ultimately, 72 participants were enrolled in the study and randomly assigned in a 1:1 ratio to the intervention group receiving the study product (n=36)(n=36)(n=36) or the control group (n=36)(n=36)(n=36). The process of qualification, randomization, and follow-up is presented in a flowchart compliant with the CONSORT standard.
Inclusion criteria included:
- 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 included severe infections, systemic diseases, immune disorders, congenital defects, food allergies, active inflammatory diseases of the oral cavity, peri-odontal disease, and the presence of fixed orthodontic appliances. Children who had taken antibiotics, anti-inflammatory medications, glucocorticosteroids, probiotics, vitamin supplements, or other products that could affect the parameters assessed within three months of the study were also excluded. Partial or complete refusal of a dental exami-nation by the child or their guardian was also an exclusion criterion.
2.2. Randomization and Blinding A 1:1 randomization sequence was generated by an investigator not involved in the further stages of the study using IBM SPSS Statistics, version 27.0, and the Microsoft Excel randomization tool. Each participant was assigned a unique allocation code corresponding to the control or intervention group.
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
- None
盲法说明
randomised trial
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Children in the intervention group received commercially available chewable tablets containing 10 mg
Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. The preparation also contained isomalt, sucralose, natural strawberry flavor, magnesium stearate, and xylitol at 200 mg per tablet (Acidolac Dentifix Kids, Polpharma, Poland).
干预措施: Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. (Dietary Supplement)
control
Saliva samples were collected before the intervention and after 14 days of follow-up, between 8:00 AM and 10:00 AM. Parents and guardians were instructed to ensure that children did not consume any food or drink, except water, for at least 60 minutes prior to collection, and did not engage in oral hygiene. Unstimulated whole saliva was collected in sterile polypropylene tubes. Immediately after collection, samples were refrigerated and then centrifuged for 10 minutes at 4°C to remove cells, food debris, and other con-taminants. The resulting supernatant was divided into working aliquots and stored at -80°C until assayed. Samples underwent one freeze-thaw cycle.
For stimulated saliva collection, a Salivette kit was used according to the manufac-turer's instructions (Sarstedt, Nümbrecht, Germany). The child chewed a sterile insert for approximately 2-3 minutes, after which it was placed in a dedicated tube using sterile forceps. Samples were centrifuged at 1000 × g for 5 minutes at 4°C.
结局指标
主要结局
Change in salivary pH
时间窗: Baseline (Day 0) and Day 14
Unstimulated saliva pH measured between 8:00-10:00 AM under standardized preanalytical conditions.
次要结局
- Change in salivary secretory IgA (sIgA)(Baseline (Day 0) and Day 14)
- Change in salivary human β-defensin 2 (hBD-2)(Baseline (Day 0) and Day 14)
研究者
Małgorzata Jamka-Kasprzyk
assistant,dentist,department of pediatric dentistry Jagiellonian University Medical College in Krakow
Jagiellonian University