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

Study Overview
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Brief Summary
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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.

Official Title
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Studie Van de Vaginale Microbiota en Het Potentieel Van Een Vaginale Zalf Met Probiotica Bij Vaginale Candidose

Conditions
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Candidiasis, Vulvovaginal

Intervention / Treatment
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* Other: Probiotic vaginal gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vulvovaginitis patients- lactobacillus gel<br>Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel. | Other: Probiotic vaginal gel<br>* Total daily administration of 2.5 ml of probiotic gel, containing three lactobacilli (Lactobacillus rhamnosus GG, Lactobacillus pentosus KCA1 and Lactobacillus plantarum WCFS1). Final dosage per gram of gel: 10^9-10^10 colony forming units of lactobacilli.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal persistence of Candida species | 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. | through study completion, estimated 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical scores of patients | 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. | through study completion, estimated 1 year | 
| Microbiome analysis | 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). | through study completion, estimated 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal, yeast infection, candida, candidosis