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CTRI Number  CTRI/2026/04/108493 [Registered on: 16/04/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study on the Safety and Benefits of Probiotic Treatment for Women with Vaginal Infection 
Scientific Title of Study   A Randomized, Double-Blind, Single-Centre, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Probiotic (Lactic Acid Bacteria) in Women with Bacterial Vaginosis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2603 V 1.0 Dated 26 Jan 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha Srinivasan  
Designation  Principal Investigator 
Affiliation  Currex Hospital 
Address  No. 55 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli KS Halli, Bengaluru, Karnataka India

Bangalore
KARNATAKA
560049
India 
Phone  8866445657  
Fax    
Email  dranusha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi LM 
Designation  HOD Clinical Operations 
Affiliation  SAMAHITHA RESEARCH SOLUTIONS 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.

Bangalore
KARNATAKA
560069
India 
Phone  09739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query  
Name  Ms Mamatha B Gokavi 
Designation  Project Manger  
Affiliation  SAMAHITHA RESEARCH SOLUTIONS 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  mamatha@samahitha.com  
 
Source of Monetary or Material Support  
AceOne Rs,CEO- AceOne Rs Suite 313, 14631 Route 29, Centreville, VA 20111, USA 
 
Primary Sponsor  
Name  AceOne Rs 
Address  AceOne Rs Suite 313, 14631 Route 29, Centreville, VA 20111, USA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
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 Anusha Srinivasan  Currex Hospital   Ground floor,OPD 6,No 55,56,Seegehalli Main Road, Bhoo samartha Layout,Seegehalli, KS Halli
Bangalore
KARNATAKA 		 06364898825

anushasrinivasan47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N760||Acute vaginitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inert oral capsule  -fixed duration of 90 consecutive days. -The route of administration will be oral. -Dose: 1 capsule twice daily after food 
Intervention  Probiotic Supplement  -Total daily dose 50 billion CFU/day (Test arm only) -fixed duration of 90 consecutive days. -The route of administration will be oral. -Dose: 1 capsule twice daily after food 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Female participants aged 19 to 50 years
2. Clinical diagnosis of bacterial vaginosis confirmed by Nugent scoring with a score of 4 to 6, preferably 5 to 6, at screening
3. Experiencing symptoms of vaginal dysbiosis such as abnormal discharge odor pain burning sensation irritation or dysuria
4. Ability and willingness to provide written informed consent prior to any study specific procedures
5. Willingness and ability to comply with study procedures including scheduled visits sample collection and study product administration
6. Willingness to avoid non-study products or medications targeting vaginal or urinary tract health throughout the study period 
 
ExclusionCriteria 
Details  1. Participation in another clinical trial within the preceding 3 months
2. History of recurrent urinary tract infections defined as two or more infections within six months or three or more infections within 12 months
3. Regular use of antibiotics antibacterial agents steroids or immunosuppressants
4. Use of products or medications targeting vaginal or urinary tract health within the 12 weeks prior to screening
5. Use of non-study vaginal products such as vaginal moisturizers vaginal estrogen douches or soaps applied intravaginally during the study period
6. Pregnancy lactation or intention to conceive during the study period
7. Known hypersensitivity or allergy to any component of the study product
8. Current or recent history of significant systemic illnesses including but not limited to cardiovascular immune respiratory gastrointestinal liver biliary renal urinary nervous system musculoskeletal psychiatric disorders malignancies or active vaginal or urinary tract infections bleeding or abnormalities unrelated to bacterial vaginosis
9. Diagnosed vaginal or pelvic conditions
10. Use of vaginal-related birth control devices including intrauterine devices or vaginal rings
11. Uncontrolled hypertension defined as systolic greater than or equal to 160 mmHg or diastolic greater than or equal to 100 mmHg
12. Uncontrolled diabetes defined as HbA1c greater than 6 point 5 percent
13. Laboratory abnormalities outside normal reference ranges considered clinically significant by the Principal Investigator including creatinine liver function tests AST ALT and thyroid stimulating hormone
14. Participation in or receipt of acupuncture or other vaginal treatments for vaginal health within one week of screening
15. Current or recent history of smoking or substance abuse within six months
16. Participants who in the opinion of the Principal Investigator are unsuitable for participation due to medical safety or compliance considerations that may interfere with study assessments or endpoints 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in Nugent score
Definition Difference in Nugent score on a 0 to 10 scale from baseline Day 0 to end of treatment Day 90
Assessment Method Gram stained vaginal smear evaluated by a trained microbiologist
Time Points Day 0 baseline Day 30 Day 60 and Day 90
Success Criterion Significant increase in Lactobacillus dominated microbiota with Nugent score less than or equal to 3 compared to baseline

2. Increase in beneficial vaginal bacteria specifically Lactobacillus species
Definition Quantitative change in Lactobacillus species DNA copies per milliliter in vaginal samples
Assessment Method Quantitative PCR targeting L helveticus and other beneficial species
Time Points Day 0 and Day 90
Success Criterion Statistically significant increase in beneficial lactobacilli compared to baseline and placebo 		 Visit 1 (Day 0)
Visit 2 (Day 30±2 days)
Visit 3 (Day 60±2 days)
Visit 4 (Day 90±2 days)
 
 
Secondary Outcome  
Outcome  TimePoints 
The study will evaluate the safety and effectiveness of probiotics in women with bacterial vaginosis. Key outcomes include changes in Nugent score and levels of beneficial Lactobacillus species in vaginal samples. The study will also assess reduction in harmful bacteria, vaginal pH, and vulvovaginal symptoms such as discharge odor burning and dysuria. Safety and tolerability will be monitored through adverse events, vital signs, and laboratory tests. Assessments will occur at baseline and multiple time points during the 90-day study period. The results will provide evidence on whether the probiotic is safe and helps restore a healthy vaginal microbiota.  Visit 1 (Day 0)
Visit 2 (Day 30±2 days)
Visit 3 (Day 60±2 days)
Visit 4 (Day 90±2 days)
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2 
Date of First Enrollment (India)   27/04/2026 
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="8"
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  

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of oral Lactobacillus helveticus probiotics in women with bacterial vaginosis (BV). BV is a common vaginal infection caused by a reduction in beneficial Lactobacillus species and overgrowth of pathogenic bacteria, leading to symptoms such as abnormal discharge, odor, irritation, and discomfort. Standard antibiotic treatments are effective short-term but have high recurrence rates, partly due to incomplete restoration of protective vaginal bacteria. Probiotics aim to restore healthy Lactobacillus levels, lower vaginal pH, inhibit pathogens, and improve symptoms. This study will assess changes in Nugent score, vaginal pH, microbiota composition, and patient-reported symptoms to determine the safety and potential benefits of Lactobacillus helveticus supplementation.


 
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