| CTRI Number |
CTRI/2025/12/099623 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare Oral Probiotics and Standard Antibiotic Therapy for treating women with Bacterial Vaginosis |
|
Scientific Title of Study
|
Oral Probiotics vs Standard Antibiotic Therapy for Bacterial Vaginosis- A Randomised, Double Blind, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Chandak |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institite of Higher Education And Research(du) |
| Address |
Arihant Apartments
JNMC Campus, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
917559302355 |
| Fax |
|
| Email |
sschandak88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjivani Wanjari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institite of Higher Education And Research(DU) |
| Address |
Dept of Obstetrics and Gynecology
JNMC, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822573624 |
| Fax |
|
| Email |
sanjivaniwanjari@yahoo.com.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Chandak |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institite of Higher Education And Research(du) |
| Address |
Arihant Apartments
JNMC Campus, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7559302355 |
| Fax |
|
| Email |
sschandak88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research(DU), Sawangi(Meghe), Wardha(Maharashtra)- 442001, India |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Chandak |
| Address |
JNMC, DMIHER(DU), Sawangi (Meghe), Wardha(Maharashtra)- 442001 , India |
| Type of Sponsor |
Other [self] |
|
|
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 Sakshi Chandak |
Acharya Vinoba Bhave Rural Hospital |
Department of Obstetrics and Gynecology,JNMC, DMIHER(DU), SAWANGI(Meghe)
Wardha
MAHARASHTRA |
07559302355
sschandak88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- DMIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PROBIOTIC |
ORAL PROBIOTICS will be given once daily for 10 days |
| Comparator Agent |
Tab METRONIDAZOLE 400 mg |
STANDARD THERAPY OF Tab METRONIDAZOLE 400 mg thrice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Consenting women in age group of 18-45 years,
2. Presenting with discharge per vaginum
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Women with any other vaginal or cervical pathology like cervical polyp, cervical erosion, carcinoma cervix, etc.
3. Women who have had previous treatment for Bacterial vaginosis
4. Menstruating at the time of examination
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RECURRENCE OF BACTERIAL VAGINOSIS BY ASSESSING NUGENT SCORE (IF ABOVE SEVEN) OR AMSELS CRITERIA POSITIVE |
After 30 days of giving treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. patients’ satisfaction by life style questionnaire |
After 30 days of giving treatment |
| 2. Side effects |
After 30 days of giving treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/12/2025 |
| 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="0"
Months="6"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sschandak88@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 18-09-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Bacterial Vaginosis is a polymicrobial syndrome
where the lactobacilli-dominated vaginal microflora is replaced by a mix of
other, mainly anaerobic bacteria species. Renewed attention has recently been focused on
approaches involving alternative ‘natural’ treatments that could be effective
in the microbiological and clinical resolution of the condition without side
effects. A meta-analysis
involving 10 RCTs with a low or moderate risk of bias, suggested that the
treatment with probiotics alone was more effective in the therapy of Bacterial
Vaginosis for both short- and long-term; however, the probiotics used after
antibiotic treatment was effective only for a short term
Thus, probiotics rather
than antibiotics have promising results in reducing the recurrence rate of
bacterial vaginosis
Thus, the aim of the study is ’to compare the efficacy of standard therapy vs
oral probiotics in women with bacterial vaginosis’ 100 women with bacterial vaginosis will be randomised into 2 equal groups and each group will be given either oral probiotics or Metronidazole(standard treatment) and assessed after 30 days to see for recurrence of bacterial vaginosis. Hypothesis: Probiotics confer long term benefit for treatment of Bacterial Vaginosis as compared to Standard Antibiotics. |