Actively Recruiting
Use of Postbiotic as Adjunct Treatment for Vaginal Candidiasis in Women
Led by Min-Tze LIONG · Updated on 2024-07-05
118
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Min-Tze LIONG
Lead Sponsor
A
AIMST University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravaginal postbiotic at a dose of 1g/day as an additional treatment for vaginal candidiasis in women. This condition, caused mainly by the overgrowth of Candida albicans, leads to uncomfortable symptoms such as itching, burning, and abnormal discharge, affecting many women worldwide. The study aims to compare the effects of postbiotic to a placebo over a 4-week period, exploring its potential as an alternative to traditional antifungal treatments due to concerns about drug resistance and recurrence. Participants will be randomly assigned to receive either the postbiotic or a placebo device daily for 4 weeks. The treatment is administered intravaginally, and the study is designed with triple masking to reduce bias. The trial includes a control group receiving the placebo to evaluate the adjunct effect of postbiotic on vaginal candidiasis. During the study, women will undergo various assessments including vaginal sample collections to analyze microbiota profiles using advanced sequencing methods. Researchers will also measure pathogenic yeast presence through PCR testing and assess quality of life changes using questionnaires. The study involves monitoring over the 4-week treatment period to evaluate the impact of postbiotic on infection and symptoms, with careful safety and adherence tracking throughout participation.
CONDITIONS
Brief Title
Postbiotic as Adjunct Treatment for Vaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who are sexually active
- Confirmed diagnosis of vaginal candidiasis based on clinical symptoms such as creamy whitish vaginal discharge and vulva itchiness
- Willingness to commit to the full duration of the study
You will not qualify if you...
- Long-term medication use (6 months or more) for any illness
- Pregnancy
- Menopause
- Removal of uterus and/or cervix
- Presence of cervical intraepithelial neoplasia
- Use of vaginal suppository treatments within 4 weeks prior to study entry
- Use of oral medication or vaginal therapies such as hormones or estrogen within 4 weeks prior to study entry
- Use of vaginal estrogen cream, ring, or tablet within 4 weeks prior to study entry
- Use of vaginal moisturizers, lubricants, or homeopathic preparations within 4 weeks prior to study entry
- Use of spermicide agents within 4 weeks prior to study entry
- Pelvic or gynecologic surgery within 6 months prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive postbiotic or placebo as an adjunct treatment against vaginal candidiasis.
Daily administration with periodic visits during treatment
Trial Site Locations
Total: 2 locations
1
Sumita Hospital
Lucknow, Aliganj, India, 226024
Actively Recruiting
2
AIMST University
Bedong, Kedah, Malaysia
Not Yet Recruiting
Research Team
S
Sumita Bhatia, MD
M
Min Tze Liong, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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