| CTRI Number |
CTRI/2025/07/090877 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of probiotic intervention and oral mucosal changes in Tobacco chewers |
|
Scientific Title of Study
|
Assessing the effect of Probiotic on Oral Mucosal Cytomorphometry and
Candida Species Colonisation in Habitual Tobacco Chewers: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepa Jose |
| Designation |
Associate Professor |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Oral Pathology,
Mar Baselios Dental College,
Kothamangalom.
Ernakulam
KERALA
686691
India |
| Phone |
9747593249 |
| Fax |
|
| Email |
dr.deepajose00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Jose |
| Designation |
Associate Professor |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Oral Pathology,
Mar Baselios Dental College,
Kothamangalom.
Ernakulam
KERALA
686691
India |
| Phone |
9747593249 |
| Fax |
|
| Email |
dr.deepajose00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepa Jose |
| Designation |
Associate Professor |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Oral Pathology,
Mar Baselios Dental College,
Kothamangalom.
Ernakulam
KERALA
686691
India |
| Phone |
9747593249 |
| Fax |
|
| Email |
dr.deepajose00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mar Baselios Dental College, Kothamangalom |
|
|
Primary Sponsor
|
| Name |
Dr Deepa Jose |
| Address |
Associate Professor,
Department of Oral Pathology,Preclinical Block,II nd floor, Kothamanglom, 686691,Kerala, India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Deepa jose |
Mar Baselios Dental College |
Thankalom, Kothamangalom 686691
Ernakulam
KERALA |
9747593249
dr.deepajose00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MBDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Habitual Tobacco Chewing Habit for a minimum of 6 months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Single arm trial |
| Intervention |
Probiotics |
Probiotics will be administered for a duration of 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Participants age ranging from 18-40 years
History of use of commercial tobacco products for a minimum of 6 months |
|
| ExclusionCriteria |
| Details |
Participants who had undergone any type of treatment for tobacco lesions
Participant with any oral potentially malignant or malignant lesion
Participants with any systemic illness
Recent history of Antibiotics usage
Participants with history of allergy to dairy products
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Alteration in candida species
colonization and cytomorphometry in tobacco users after probiotic intervention. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Well being |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
08/09/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Total participants involved in the study are 126. Smears will be taken from buccal muocsoa of tobacco users to identity candidia species colonisation and cytomorphometric evaluation from each participants before and after probiotic interventions.
|