Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorThe Archer-Daniels-Midland Company

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Archer-Daniels-Midland Company

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborator