Predicting oral microbiome profile and other health related markers from metabolites
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 59.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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)
Time Frame: The single time point at which the data will be analysed will be 52 weeks from the start of the study.
and
Time Frame: 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)
Time Frame: The single time point at which the data will be analysed will be 52 weeks from the start of the study.
Secondary Outcomes
- 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.)
Investigators
Dr Palok Aich
MicrobioTx Health Private Limited