Efficacy of Oral Probiotics on Cysteine-Induced Halitosis in Healthy Adult Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups
研究概览
简要总结
The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.
详细描述
This is a double-blind, randomized controlled colonization pilot study with no crossover to evaluate the efficacy of probiotic lozenges on halitosis in healthy adults.
Participants will be randomly assigned to 2 groups consuming probiotic lozenge containing Streptococcus salivarius M18 and K12 and with prebiotic over a 13 day period. Breath scores will be measured at predetermined time points pre and post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be otherwise healthy,
- •practice good oral hygiene,
- •18 - 70 years of age
排除标准
- •on antibiotic therapy,
- •immunocompromised (have a weakened immune system)
- •history of autoimmune disease,
- •allergy or sensitivity to dairy,
- •have an active periodontal disease, any known allergy or sensitivity to components of the test product or cysteine solution.
研究组 & 干预措施
Oral probiotic lozenges
Oral probiotic lozenges containing Streptococcus salivarius M18 and Streptococcus salivarius K12 and prebiotic
干预措施: In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath (Dietary Supplement)
Placebo lozenges
Oral lozenges
干预措施: Placebo (Other)
结局指标
主要结局
Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups
时间窗: 13 days
Study will determine the change in Volatile Sulphur Compounds (VSCs) as measured in ppb, following application of probiotic lozenges containing Streptococcus salivarius K12, Streptococcus salivarius M18 and prebiotic compared with a placebo lozenge. Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to post cysteine mouthrinse before the lozenge application and 13 days after once a day lozenge application with the level of significance of p≤0.05 across the probiotic and placebo lozenge. Appropriate statistical analysis software (e.g. Microsoft Excel) will be used to analyse the data
次要结局
未报告次要终点
研究者
John Hale
Chief Technology Officer
BLIS Technologies Limited