| CTRI Number |
CTRI/2026/01/101106 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [postbiotic as adjunct treatment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study of an Oral Treatment for Vaginal Yeast Infections in Indian Women. |
|
Scientific Title of Study
|
Use of oral postbiotic as adjunct treatment for vaginal candidiasis in women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL,VERSION: 1.0 DATE: 05 APRIL 2024 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumita Bhatia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Paramedical Sciences |
| Address |
Dhund purva tiraha
Barethi
Lucknow
UTTAR PRADESH
225301
India |
| Phone |
9235697555 |
| Fax |
|
| Email |
bhatiadrsumita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Bhatia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Paramedical Sciences |
| Address |
Dhund purva tiraha
Barethi
Lucknow
UTTAR PRADESH
225301
India |
| Phone |
9235697555 |
| Fax |
|
| Email |
bhatiadrsumita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Bhatia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Paramedical Sciences |
| Address |
Dhund purva tiraha
Barethi
Lucknow
UTTAR PRADESH
225301
India |
| Phone |
9235697555 |
| Fax |
|
| Email |
bhatiadrsumita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumita Hospital
HS 1/10 SectorA Jankipurum Ram Ram bank crossing Lucknow 226024 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Sumita Bhatia |
| Address |
Gynecologist, Sumita Hospital
Associate Professor
Sumita Hospital
HS 1/10 SectorA Jankipurum Ram Ram bank crossing Lucknow 226024 Uttar Pradesh 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 Samita Bhatia |
Sumita Hospital |
Room No - 1.0
National Institute of Paramedical Sciences
Lucknow, UP, India
Lucknow
UTTAR PRADESH |
9235697555
bhatiadrsumita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Narayana Diagnostics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Postbiotic Tablet
Dose: 0.5 g per tablet, once daily |
Once-daily oral postbiotic tablet (0.5 g) for 4 weeks.
Given after a standard 3-day antifungal therapy (Candid V3 suppository: Clotrimazole 200 mg × 3 days). |
| Comparator Agent |
Placebo Tablet
Dose: Same as IP (0.5 g/tablet/day, orally |
Once-daily placebo tablet for 4 weeks, identical in look/feel.
Also given after the same 3-day standard antifungal therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who are sexually active
Confirmed with candidiasis as confirmed via clinical observations which include creamy whitish vaginal discharge and vulva-vaginal itchiness
Willing to commit throughout the experiment |
|
| ExclusionCriteria |
| Details |
Long term medication (6 months or more) for any illnesses
Pregnant
Menopaused
Uterus and/or cervix removed
Cervical intraepithelial neoplasia
Vaginal suppository treatments within 4-weeks prior to entering the study
Oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study
Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study
Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study
Have used spermicide agent within 4-weeks prior to entering the study
Have pelvic or any gynecologic surgery 6-months prior to entering the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in vaginal Candida (yeast) profile
Measured by qPCR from high vaginal swab.
Change in vaginal microbiota (bacterial) profile
Measured by Next-Generation Sequencing (NGS).
Clinical symptom improvement
Measured through validated clinical questionnaires:
Vaginal Assessment Scale (VAS)
Vulvar Assessment Scale (VuAS)
Quality of life improvement
Measured using Vulvovaginal Symptom Questionnaire (VSQ). |
at Week 0,1,2,3,4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Differences in clinical symptoms by VAS, VuAS
Differences in vaginal Candida levels by qPCR
Differences in vaginal bacterial profiles by NGS
Differences in protein concentration & gene expression by qPCR & protein assays
Differences in quality of life by VSQ
|
at Week 0,1,2,3,4 |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 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="3"
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 randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of an oral postbiotic (0.5 g/day) as an adjunct treatment for vaginal candidiasis in women. A total of 118 sexually active women with clinically confirmed vaginal candidiasis will be enrolled and randomized in a 1:1 ratio to receive either the postbiotic or a placebo for 4 weeks. Prior to randomization, all participants will receive standard antifungal therapy with a 3-day clotrimazole vaginal suppository.
Participants will be assessed weekly for clinical symptoms, quality of life, and changes in vaginal microbiota. High vaginal swabs will be collected at baseline and weekly to evaluate Candida levels, bacterial profiles, protein concentrations, and immune gene expression using qPCR and next-generation sequencing. The study seeks to determine whether oral postbiotics can enhance symptom improvement, support vaginal microbiota balance, and reduce recurrence risk when used as an adjunct to standard antifungal treatment.
The results are expected to generate important evidence on the potential benefits of postbiotics in managing vaginal candidiasis and improving women’s vaginal health and overall well-being. |