Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: 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
Sponsors
Dr Sumita Bhatia
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).Timepoint: at Week 0,1,2,3,4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: at Week 0,1,2,3,4 | — |
Countries
India
Contacts
Public ContactDr Sumita Bhatia
National Institute of Paramedical Sciences
Outcome results
None listed