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

NCT03975569 | Completed

• 2 other identifiers: 16/7/66B300201628296
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

vaginal, yeast infection, candida, candidosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical scores of patients

  through study completion, estimated 1 year

• Microbiome analysis

  through study completion, estimated 1 year

Study Arms (1)

vulvovaginitis patients- lactobacillus gel

EXPERIMENTAL

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

Other: Probiotic vaginal gel

Interventions

Probiotic vaginal gel 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.

vulvovaginitis patients- lactobacillus gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Torulopsis; Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Gilbert Donders, MD, PhD

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: June 5, 2019
• Study Start: April 4, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 5, 2019

Record last verified: 2019-06