Back to resultsStudy of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis
Primary Purpose
Candidiasis, Vulvovaginal
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic vaginal gel
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Vulvovaginal focused on measuring vaginal, yeast infection, candida, candidosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vulvovaginitis patients- lactobacillus gel
Arm Description
Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT03975569
First Posted
February 12, 2019
Last Updated
June 3, 2019
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT03975569
Brief Title
Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis
Official Title
Studie Van de Vaginale Microbiota en Het Potentieel Van Een Vaginale Zalf Met Probiotica Bij Vaginale Candidose
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Vulvovaginal
Keywords
vaginal, yeast infection, candida, candidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vulvovaginitis patients- lactobacillus gel
Arm Type
Experimental
Arm Description
Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.
Intervention Type
Other
Intervention Name(s)
Probiotic vaginal gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaginal persistence of Candida species
Description
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.
Time Frame
through study completion, estimated 1 year
Secondary Outcome Measure Information:
Title
Clinical scores of patients
Description
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.
Time Frame
through study completion, estimated 1 year
Title
Microbiome analysis
Description
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).
Time Frame
through study completion, estimated 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis
We'll reach out to this number within 24 hrs