| CTRI Number |
CTRI/2025/01/078870 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predict oral microbiome profile from metabolites |
|
Scientific Title of Study
|
Predicting oral microbiome profile and other health related markers from metabolites |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
|
Source of Monetary or Material Support
|
| Funds provided by MicrobioTx Health Pvt Ltd, 8th Main, Koramangala, Bangalore, 560034, India |
| Infrastructure and clinical support provided by Institute of Dental Sciences, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha 751003 India |
|
|
Primary Sponsor
|
| Name |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore, 560034
|
| Type of Sponsor |
Other [Startup] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupsa Das |
Institute of Dental Sciences |
Department of Oral Medicine and Radiology,
Siksha O Anushandhan (Deemed to be university)
Bhubaneswar, Odisha -751003
Khordha
ORISSA |
7008067553
rupsadas@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E638||Other specified nutritional deficiencies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
For OSCC - 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
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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)
and
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) |
The single time point at which the data will be analysed will be 52 weeks from the start of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|