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

NCT ID: NCT03975569

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-04
• Study Completion Date: 2017-03-31

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.

Conditions

Candidiasis, Vulvovaginal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vulvovaginitis patients- lactobacillus gel

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

Group Type: EXPERIMENTAL

Probiotic vaginal gel

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Ethisch Comité, UZA

Prof. Dr. Gilbert Donders, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

B300201628296

Identifier Type: OTHER

Identifier Source: secondary_id

16/7/66

Identifier Type: -

Identifier Source: org_study_id