Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Candidiasis, Vulvovaginal

Treatments: Other: Probiotic vaginal gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03975569

16/7/66

B300201628296 (Other Identifier)

Details and patient eligibility

About

This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• willing to adhere to protocol
• premenopausal
• positive Candida microscopy and/or culture
• at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner

Exclusion criteria

• vaginal use of any products 1 week or less before randomization
• use of oral or local antimycotic treatment 1 week or less before randomization
• unprotected sexual contact 24 hours preceding randomization
• vaginal douching 24 hours preceding randomization
• patient does not agree to participate in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

vulvovaginitis patients- lactobacillus gel

Experimental group

Description:

Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.

Treatment:

Other: Probiotic vaginal gel