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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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