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Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT02859493
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : August 9, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Lesaffre International

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. The administration of yeast will be local (vaginal).

Condition or disease Intervention/treatment Phase
Candidiasis, Vulvovaginal Device: Saccharomyces cerevisiae Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)
Actual Study Start Date : August 2016
Actual Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Active Comparator: Saccharomyces cerevisiae
Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days.
Device: Saccharomyces cerevisiae
Placebo Comparator: Maize starch and magnesium stearate
Placebo presented in a vaginal capsule. 1 capsule a day for 14 days
Device: Placebo



Primary Outcome Measures :
  1. Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis [ Time Frame: after 7 days and 14 days of treatment ]
    valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria.
  • Amenorrheic subject, or subject having a regular menstrual cycle.
  • Subject psychologically able to understand the study related information and to give a written informed consent.
  • Subject having given freely and expressly her informed consent.
  • Subject able to comply with protocol requirements, as defined in the protocol.
  • Subject affiliated to a health social security system.
  • Female subjects of childbearing potential should use a medically accepted contraceptive regimen (except latex condom, latex diaphragm, spermicidal) during the D0-D14 period, since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end, at the investigator's discretion

Exclusion Criteria:

In terms of population

  • Pregnant or nursing woman or planning a pregnancy during the study.
  • Post-menopausal women.
  • Subject who will have her period between the first and the second visit to the gynaecologist (between D0 and D7).
  • Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
  • Subject in a social or sanitary establishment.
  • Subject suspected to be non-compliant according to the investigator's judgment.
  • Subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period, being in an exclusion period for a previous study, having tested a food supplement or a medication in the 4 previous weeks.
  • Subject in an emergency situation. In terms of associated pathology
  • Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
  • Subject suffering from systemic diseases using concurrent therapy that may interfere with the evaluation of the study results.
  • Subject with a known allergy to one of the component of the study products or to the medication (vaginal ovule and/or antifungal cream).
  • Subject presenting an hypersensitivity to any antifungal of imidazole family or to one of the excipient.
  • Uterine or vaginal bleeding of unknown origin
  • Subject with known sexually transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus or HIV 1 or 2.
  • Immunocompromised subjects

Relating to previous or ongoing treatment

• Subject undergoing a topical treatment on the test area or a systemic or intravaginal treatment:

  • antibiotics currently or within the past 2 weeks (systemic antibiotic are accepted if the treatment was stopped until the day before the inclusion visit)
  • anti-fungal agents currently or within the past 2 weeks,
  • anticoagulant within the past 2 weeks and during the study,
  • anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study,
  • corticosteroids during the 2 previous weeks and during the study,
  • retinoids and/or immunosuppressors during the 3 previous months and during the study,
  • any medication stabilized for less than one month.

In terms of lifestyle

  • Subject planning to change her usual hygiene habits and products during the study.
  • Subjects not willing to stop taking probiotics dietary supplements and food products enriched with probiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859493


Locations
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France
Dermscan
Villeurbanne, France, 69100
Sponsors and Collaborators
Lesaffre International

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Responsible Party: Lesaffre International
ClinicalTrials.gov Identifier: NCT02859493     History of Changes
Other Study ID Numbers: 15E2899
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases