RecruitingNot Applicable

Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

India126 participantsStarted 2024-10-15

Plain-language summary

This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. Premenopausal women aged 18-50 years.
✓. Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).
✓. Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
✓. Culture growth of Candida spp. causing VVC.
✓. Random Capillary Blood Glucose of \< 110mg/dl.
✓. Willingness to consume the study products for the entire study duration.
✓. Willing to complete all study procedures and comply with study requirements.
✓. Willing to abstain from other supplements or medication.

Exclusion criteria

✕. Post-menopausal and peri-menopausal women.
✕. Pregnant/breast-feeding women.
✕. Use of oral or vaginal anti-fungal medication in the last 14 days.
✕. Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
✕. Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
✕. Known allergy to Clotrimazole.
✕. Women not willing to use any form of vaginal medication during the study.
✕. Use of vaginal douching.

What they're measuring

Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.

Timeframe: Day 0, Day 180

Trial details

NCT IDNCT06480604

SponsorThe Archer-Daniels-Midland Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

ADM Medical Team

+441460243230 medical@protexin.com

View on ClinicalTrials.gov More Vulvovaginal Candidiasis trials