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Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

NCT06480604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-11-07

No results posted yet for this study

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).

Conditions

  • Vulvovaginal Candidiasis

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    collaborator INDUSTRY

  • The Archer-Daniels-Midland Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06480604 on ClinicalTrials.gov