| CTRI Number |
CTRI/2026/01/100576 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of Probiotic Therapy Along with Antibiotics for Treating and Preventing Recurrence of Bacterial Vaginosis in Women |
|
Scientific Title of Study
|
Effectiveness of a multistrain probiotic formulation containing Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Fructooligosaccharides (Normoflora BV) in the treatment and recurrence prevention of bacterial vaginosis,A randomized open label trial |
| 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 S Sarumathy |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) |
| Address |
SRM College of Pharmacy
Department of Pharmacy Practice, SRM College of Pharmacy,SRMIST, Kattankulathur, Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010530419 |
| Fax |
|
| Email |
sarumats@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinodini S |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) |
| Address |
ground floor, Department of Gynaecology, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Chengalpattu
Tamil Nadu, 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940432051 |
| Fax |
|
| Email |
vinodhis@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Varsha M |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology (SRMIST) |
| Address |
SRM College of Pharmacy
Department of Pharmacy Practice, SRM College of Pharmacy,SRMIST, Kattankulathur, Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9789869888 |
| Fax |
|
| Email |
mercy1707@gmail.com |
|
|
Source of Monetary or Material Support
|
|
SRM College of Pharmacy, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital And Research Centre |
| Address |
SRM Medical College Hospital And Research Centre, SRM Nagar, Potheri, Chengalpattu,
Tamil Nadu 603203 |
| Type of Sponsor |
Research institution |
|
|
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 S Sarumathy |
SRM Medical College Hospital & Research Centre |
Department of Gynecology,
SRM Medical College Hospital And Research Centre, SRM Nagar, Potheri, Chengalpattu,
Kancheepuram
TAMIL NADU |
7010530419
sarumats@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metronidazole 500 mg |
Metronidazole 500 mg will be administered orally once daily for a duration of seven days as standard treatment for bacterial vaginosis. |
| Comparator Agent |
Probiotic Formulation (Normoflora BV)
Multistrain probiotic containing L. crispatus, L. jensenii, L. gasseri, L. reuteri, L. rhamnosus, L. plantarum, L. fermentum, B. bifidum, and FOS
|
Standard antibiotic therapy with metronidazole 500 mg will be administered orally once daily for seven days along with a multistrain probiotic formulation Normoflora BV containing Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bifidobacterium bifidum and fructooligosaccharides administered orally once daily for a duration of thirty days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Female participants aged 18–50 years,premenopausal, with regular menstrual cycles (eumenorrhoea: every 28 ± 10 days).
2. Confirmed diagnosis of bacterial vaginosis,defind by Nugent score at screening
3. Willing and able to provide written informed consent.
4. Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea)shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
5. No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)as confirmed by a qualified gynecologist.
6. Susceptibility to recurrent vaginitis and/or urinary tract infections, as well as bacterial vaginitis confirmed at visit I.
7. Able to attend scheduled study visits and comply with all study procedures and protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Recent treatments or exposures including systemic or intravaginal antibiotics, antifungals, or vaginal probiotics within the past 14–30 days
2. Current medical conditions such as co-infection with other vaginal pathogens (e.g., vulvovaginal candidiasis, trichomoniasis, STIs), neoplastic disease, or significant mental illness
3. Vulnerable populations including pregnant or breastfeeding women
4. Contraceptive or hormonal interventions including use of mechanical contraceptives (e.g., diaphragms, most IUDs except Mirena), NuvaRing, or vaginal hormonal preparations (e.g., Vagifem, Ovestin, estrogens)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Normoflora BV compared to Metronidazole in the treatment of bacterial vaginosis (BV), assessed by changes in Nugent score over 12 weeks.
2.To compare the recurrence rate of BV within 12 weeks post-treatment between the two study groups, based on Nugent scoring.
3.To assess the change in vaginal pH over 12 weeks as a surrogate marker of vaginal microbial environment and potential for normal microbiota restoration.
|
1. Efficacy was assessed by changes in Nugent score from baseline (Day 0) to Week 12 (Month 3). Additional Nugent score assessments were performed at Day 15, Day 30, and Month 2 to evaluate early response and durability of treatment.
2. Recurrence of bacterial vaginosis was evaluated at Week 4,8,12 post-treatment using Nugent scoring, with recurrence defined as a Nugent score
3. Vaginal pH was measured at baseline,Day15, Day30, Month 2 and Month 3 to assess restoration and maintenance of the normal vaginal microbial environment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess improvement in symptoms using the reproductive tract infection (RTI) symptom
survey.
2. To monitor and record adverse drug reactions throughout the study. |
1. RTI symptom scores were assessed at baseline, Day 15, Day 30, Month 2, and Month 3 to evaluate improvement and sustainability of symptom relief.
2.Adverse drug reactions were monitored continuously from treatment initiation (Day 0) until the final follow-up visit at Month 3, with structured assessments conducted at each study visit. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a randomized open label clinical trial designed to evaluate the effectiveness and safety of a multi strain probiotic formulation Normoflora BV as an adjunct to standard antibiotic therapy in women with bacterial vaginosis. A total of sixty eligible participants aged eighteen to fifty years will be enrolled after ethical approval and CTRI registration and randomly allocated into two groups. The control group will receive standard treatment with oral metronidazole for seven days while the intervention group will receive metronidazole along with Normoflora BV probiotic for the same duration. Participants will be followed over a period of three months with scheduled visits to assess clinical symptoms vaginal pH Nugent score treatment adherence safety and recurrence of infection. The primary objective is to compare treatment response and recurrence rates between the two groups. Secondary objectives include evaluation of vaginal microbiota restoration safety and tolerability of the probiotic formulation. The findings of this study are expected to provide evidence on the role of probiotic supplementation in improving treatment outcomes and preventing recurrence of bacterial vaginosis. |