| CTRI Number |
CTRI/2025/12/099934 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to Compare vaginal microbial bacteria in healthy women before and after menopause. |
|
Scientific Title of Study
|
Vaginal Microbial Ecology and Comparative Analysis between Post-Menopausal and Pre-Menopausal Healthy Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL_LRB_1811_2025, Version 1.0, date 18-Nov-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Aggarwal |
| Designation |
Senior Consultant |
| Affiliation |
Sri Laxmi Hospital |
| Address |
Room 1, 1st floor, Sri Laxmi Hospital, Electronic city
Bangalore KARNATAKA 560100 India |
| Phone |
9742054130 |
| Fax |
|
| Email |
drabhishekagarwal542@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Debojyoti Dhar |
| Designation |
Co-Founder & Director (Business Development and Innovation) |
| Affiliation |
Leucine Rich Bio Pvt Ltd |
| Address |
Room 33, 2nd Floor,Leucine Rich Bio Pvt Ltd, HSG Anush, 15th Main Road, JP Nagar,4th Phase, Bangalore
Bangalore KARNATAKA 560078 India |
| Phone |
981839509 |
| Fax |
|
| Email |
ddhar@leucinerichbio.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mukul Maurya |
| Designation |
Director & Founder |
| Affiliation |
ProClin Research Pvt Ltd |
| Address |
Room No. 1, 1st Floor, Opp to Carewell Hospital, Near Nevri Mandir, Gufa Mandir Road, Bhopal
Bhopal MADHYA PRADESH 462030 India |
| Phone |
7032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Leucine Rich Bio Pvt. Ltd.
Phase 4, No 33, 2nd Floor HSG Anush, 15th Main Rd, J. P. Nagar, Bengaluru, Karnataka 560078 |
|
|
Primary Sponsor
|
| Name |
Leucine Rich Bio Pvt Ltd |
| Address |
Leucine Rich Bio Pvt. Ltd.
Phase 4, No 33, 2nd Floor HSG Anush, 15th Main Rd, J. P. Nagar, Bengaluru, Karnataka 560078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Abhishek Aggarwal |
Sri Laxmi Hospital |
Room No. 1, 1st floor, Doddathogur Rd, Electronic City Phase I, Electronic City, Doddathoguru, Bengaluru Bangalore KARNATAKA |
9742054130
drabhishekagarwal542@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Comparing the vaginal microbiota of healthy post-menopausal and pre-menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy individuals with no known chronic illness.
2. For post-menopausal group: more than or equal to 12 months amenorrhea (not explained by pregnancy or other medical cause).
3. For pre-menopausal group: currently pre-menopausal (menstruating) sampling not during menses.
4. Willing to abstain from vaginal intercourse, douching, or intravaginal products for 48 hours prior to sampling.
5. Willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Current menstruation (sampling must be rescheduled).
2. Pregnancy or breastfeeding.
3. Use of intravaginal antibiotics, antifungals, or probiotic suppositories within the past 2 weeks.
4. Vaginal douching or intravaginal product use in the past 48 hours.
5. Current symptomatic vaginal infection (pruritus, abnormal discharge, odour) or clinically diagnosed vaginitis at screening.
6. Current symptomatic vaginal infection (pruritus, abnormal discharge, odour) or clinically diagnosed vaginitis at screening.
7. Active sexually transmitted infection diagnosed within past 3 months (self-report or medical history).
8. Major gynecologic surgery within 3 months.
9. Chronic illness such as Type 2 diabetes, Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in vaginal microbial community alpha diversity (Shannon diversity index), relative abundance of key microbiota between post-menopausal and pre-menopausal healthy women. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between menopausal status and vaginal microbiota composition. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
12/01/2026 |
| 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="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This observational study aims at identifying and comparing the vaginal microbiota of healthy post-menopausal and pre-menopausal women. The justification of carrying out this research is informed by a number of important factors: Scientific Reasoning: The existing literature suggests that there is a significant change in the microbiome composition of the vagina that is linked to menopausal transition. Nevertheless, to create a baseline of microbiota characterization operating between diverse populations would be required to develop standardized characterizations of these alterations, which might be utilized as predictive biomarkers of menopausal condition and the associated morbidity. Clinical Implications: The differences in vaginal microbiome between pre and post-menopausal women can help us understand the pathophysiology of GSM as well as design customized measures to restore microbial balance and reduce the symptoms of the menopausal period. This knowledge has the potential to change menopausal healthcare into aggressive instead of reactive, precision-focused care. Methodology: Whole genome shotgun metagenomic sequencing allows the extensive, culture- independent characterization of the vaginal microbiota composition. This molecular method offers a comprehensive taxonomic distinction and enables the grouping of samples into Community State Type (CSTs) that have been confirmed as clinically meaningful groupings of vaginal microbiome profiles. Sample Size Consideration: The suggested sample of 50 (25 in each group) implies a useful preliminary study that can give useful preliminary information on the effect size and can guide further studies that are larger and sufficiently powered. Although larger sample sizes are usually necessary to identify weakly differing species in microbiome studies, such a scale will be suitable to detect strong compositional dissimilarities between groups in dominant taxa and measures of diversity. |