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

Candidiasis, Vulvovaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975569
• Other study ID #: 16/7/66
• Secondary ID: B300201628296
• Status: Completed
• Phase: N/A
• Start date: April 4, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2019
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

Other:
• Probiotic vaginal gel
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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