Predicting oral microbiome profile and other health related markers from metabolites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
研究概览
简要总结
The oral cavity has the second largest and most diverse microbiota after the gut, which harbors over 700 species of bacteria. It nurtures numerous microorganisms which include bacteria, fungi, viruses, and protozoa. The mouth, with its various niches, is an exceptionally complex habitat where microbes colonize the teeth’ hard surfaces and the oral mucosa’s soft tissues. Understanding the oral microbiome in health and disease gives further directions to explore the functional and metabolic alterations associated with the diseased states, and to identify molecular signatures for drug development and targeted therapies which will ultimately help in rendering personalized and precision medicine. This research focuses on three conditions where the oral microbiome is known to play a role.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •histologically proven OSCC (oral biopsies) as per ICD-10-CM diagnosis codes (C04.9, C06.9) For Gingivitis with Halitosis.
- •Gingivitis (acute/chronic) diagnosis as per ICD-10 diagnostic code K05.0-K05.1, Halitosis diagnosis as per ICD-10-CM R19.6 For Gingivitis without Halitosis- Gingivitis (acute/chronic) diagnosis as per ICD-10 diagnostic code K05.0-K05.1, Halitosis diagnosis non-confirmatory as per ICD-10-CM R19.6 For healthy.
- •Absence of OSCC, Halitosis or gingivitis.
排除标准
- 未提供
结局指标
主要结局
Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
时间窗: The single time point at which the data will be analysed will be 52 weeks from the start of the study.
and
时间窗: The single time point at which the data will be analysed will be 52 weeks from the start of the study.
Specificity: Specificity is defined as (number of microbes called deficient by both the standard of care and by MicrobioTx)/(number of microbes called deficient by standard of care)
时间窗: The single time point at which the data will be analysed will be 52 weeks from the start of the study.
次要结局
- Design probiotic formulation to improve oral microbial health(The single time point at which the data will be analysed will be 1.5 year from the start of the study.)
研究者
Dr Palok Aich
MicrobioTx Health Private Limited