Randomized Controlled Trial on the Effect of Levilactobacillus Brevis (CNCM I-5566) Probiotic Supplement on Clinical and Salivary Oral Indicators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Full mouth bleeding score
研究概览
简要总结
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. The primary objective is to assess changes in salivary biomarkers, including salivary pH and buffer capacity; microbial composition using microbiome next-generation sequencing (NGS); and clinical oral inflammatory markers, such as full mouth bleeding score and full mouth plaque score, over a 4-week period. By comparing these indicators between the two groups, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases.
详细描述
This RCT is designed to investigate the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. The study aims to provide robust evidence on the efficacy of this probiotic in promoting oral health and potentially preventing oral diseases.
Study Design:
Participants will be randomly assigned to one of two groups: the experimental group, which will receive the Levilactobacillus brevis CNCM I-5566 probiotic supplement, and the control group, which will receive a placebo. This random assignment ensures that the groups are comparable at the start of the trial, allowing for unbiased comparison of outcomes.
Duration:
The study will be conducted over a 4-week treatment period, during which participants will adhere to their assigned supplement regimen.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes.
- •Dental caries experience (DMFT) less than 4.
排除标准
- •Active or historical periodontitis.
- •Diabetes mellitus diagnosis.
- •Active or historical cancer diagnosis.
- •Antibiotic therapy within the past 3 months.
- •Currently undergoing active therapy with drugs.
- •Presence of disabilities affecting the ability to maintain oral hygiene at home.
- •Recent professional oral hygiene treatment within the last 3 months.
- •Pregnancy.
- •Presence of eating disorders.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
L. brevis
干预措施: Levilactobacillus brevis CNCM I-5566 (Dietary Supplement)
结局指标
主要结局
Full mouth bleeding score
时间窗: Baseline, 4 and 6 weeks
Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)
Salivary pH
时间窗: Baseline, 4 and 6 weeks
Assay used to define dental caries risk
Full mouth plauqe score
时间窗: Baseline, 4 and 6 weeks
Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)
次要结局
未报告次要终点
研究者
Davide Pietropaoli
Associate Professor
University of L'Aquila