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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Completed

CT.gov ID

NCT03975569

Collaborator

(none)

Enrollment

Arm

11.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Vulvovaginal	Other: Probiotic vaginal gel	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 4, 2016

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vulvovaginitis patients- lactobacillus gel Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.	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.

Arm

Intervention/Treatment

Experimental: vulvovaginitis patients- lactobacillus gel

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

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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Antwerp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ethisch Comité, UZA, Prof. Dr. Gilbert Donders, MD, PhD, University Hospital, Antwerp

ClinicalTrials.gov Identifier:

NCT03975569

Other Study ID Numbers:

16/7/66
B300201628296

First Posted:

Jun 5, 2019

Last Update Posted:

Jun 5, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ethisch Comité, UZA, Prof. Dr. Gilbert Donders, MD, PhD, University Hospital, Antwerp

vaginal, yeast infection, candida, candidosis

Additional relevant MeSH terms:

Candidiasis

Candidiasis, Vulvovaginal

Study Results

No Results Posted as of Jun 5, 2019