Double-blind Clinical Trials of Probiotic Products in Oral Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.
研究概览
简要总结
In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 20 to 40 years old.
- •More than 10^5 Streptococcus mutans (CFU/mL) of saliva.
排除标准
- •Subject has major illness.
研究组 & 干预措施
Combined probiotics (1)
Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.
干预措施: Combined probiotics (1) (Dietary Supplement)
Combined probiotics (2)
Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66.
干预措施: Combined probiotics (2) (Dietary Supplement)
Combined heat-killed probiotics (1)
Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.
干预措施: Combined heat-killed probiotics (1) (Dietary Supplement)
Combined heat-killed probiotics (2)
Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66.
干预措施: Combined heat-killed probiotics (2) (Dietary Supplement)
Probiotic metabolites
Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites.
干预措施: Probiotic metabolites (Dietary Supplement)
Placebo
Does not contain probiotics, heat-killed probiotics and related metabolites.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.
时间窗: 4 weeks.
The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the mitis salivarius-bacitracin agar (MSBA) plate for counting the CFU of Streptococcus mutans.
The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.
时间窗: 4 weeks.
The saliva was collected by the centrifuge tube before and after taking the oral tablets. IgA will be detected by enzyme-linked immunosorbent assay (ELISA).
The change from baseline microbiota at 4 weeks.
时间窗: 4 weeks.
The saliva was collected by the next-generation sequencing (NGS) saliva collection tube before and after taking the oral tablets. The changes in microbial flora will be detected by NGS.
次要结局
- The change from baseline CFU of total oral microbiota at 4 weeks.(4 weeks.)
- The change from baseline CFU of probiotics at 4 weeks.(4 weeks.)
研究者
Hsieh-Hsun Ho
R.D. Manager Doctor
Glac Biotech Co., Ltd