A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ Individuals meeting ALL of the following criteria will be enrolled for the study:

• 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.

• Ready to give voluntary, written, informed consent to participate in the study.

Locations
Other Locations
India
Life Care Hospital
RECRUITING
Nashik
AMF's Moraya Multispeciality Hospital
RECRUITING
Pune
ENT & Vertigo Clinic
RECRUITING
Pune
Vivaan Hospital
RECRUITING
Sopara
Anand Multispeciality Hospital
RECRUITING
Vadodara
Matritva Women's Hospital
RECRUITING
Vasai
Contact Information
Primary
ADM Medical Team
medical@protexin.com
+441460243230
Backup
Sanjay Dr Vaze, MBBS, MD
sanjay.v@vediclifesciences.com
+9102242172325
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2025-07
Participants
Target number of participants: 126
Treatments
Experimental: Probiotic
Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
Placebo_comparator: Placebo
Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
Related Therapeutic Areas
Sponsors
Collaborators: Vedic Lifesciences Pvt. Ltd.
Leads: The Archer-Daniels-Midland Company

This content was sourced from clinicaltrials.gov