Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

NCT02345096 | Terminated DMC

• 1 other identifier: OP090414.LES
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.

Conditions

Vulvo-vaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Enumeration of Candida albicans in a vaginal sampling

  up to 2 months

Study Arms (2)

Saccharomyces cerevisiae CNCM I-3856

ACTIVE COMPARATOR

In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.

Dietary Supplement: Saccharomyces cerevisiae

placebo

PLACEBO COMPARATOR

In this arm, subjects will be asked to consume one capsule of placebo per day.

Dietary Supplement: Placebo

Interventions

Saccharomyces cerevisiae DIETARY_SUPPLEMENT

Saccharomyces cerevisiae CNCM I-3856

Placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis
• Regularly menstruating women with normal gynaecological status
• Patient must use a contraception method
• Having given a written informed consent prior to selection
• Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

You may not qualify if:

• Pregnancy or breast feeding.
• Tumors in the genital tract or beast.
• Hypersensitivity to the study product.
• Uterine or vaginal bleeding of unknown origin.
• Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.
• Concomitant medication with antimycotics for other diagnoses.
• Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or 2.
• Immunocompromised individuals.
• Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods
• Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
• Subject under administrative or legal supervision.
• Subject who participate to a previous study within 3 months.

Sponsors & Collaborators

• Lesaffre International: lead
• Eurofins Optimed: collaborator

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

Study Officials

• Robert Cherbut, MD

  Independant gynecologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

FR (1)