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

Not Applicable

Completed

• Conditions: Candidiasis, Vulvovaginal
• Interventions: Other: Probiotic vaginal gel

• Registration Number: NCT03975569
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-04
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Study First Submitted: 2019-02-12
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-05
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vulvovaginitis patients- lactobacillus gel	Probiotic vaginal gel	Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.

Primary Outcome Measures

Name	Time	Method
Vaginal persistence of Candida species	through study completion, estimated 1 year	The presence of Candida species in the collected samples will be analyzed by microscopy, culture (clinical lab) and after DNA extraction through quantitative PCR as molecular method. This will allow to estimate relative and absolute concentrations of the suspected infectious agent, and allow to evaluate if the infection cleared or not.

Secondary Outcome Measures

Name	Time	Method
Clinical scores of patients	through study completion, estimated 1 year	By the responsible gynecologist, symptom severity (burning, itching, redness, swelling and fissures) was estimated and scored as absent, mild, moderate or severe. This will provide information about the ability of the gel to ameliorate the symptoms of vulvovaginal candidosis.
Microbiome analysis	through study completion, estimated 1 year	After Illumina MiSeq sequencing, bio-informatics tools will be used to cluster bacteria and yeasts into operation taxonomic units/ amplicon sequence variants (ASVs). Based on these ASVs, the bacterial and fungal community will be compared over the sampled periods and allow comparison of the composition over the study period. The investigators will specifically screen for ASVs that can be expected to be derived from supplied probiotic strains or that are responsible for the infection (expected Candida ASVs). Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (expected in most women to be dominated by one of four Lactobacillus species).