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

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ClinicalTrials.gov Identifier: NCT03975569
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : April 4, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

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.




Primary Outcome Measures :
  1. Vaginal persistence of Candida species [ Time Frame: 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 :
  1. Clinical scores of patients [ Time Frame: 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.

  2. Microbiome analysis [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Ethisch Comité, UZA, Prof. Dr. Gilbert Donders, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03975569     History of Changes
Other Study ID Numbers: 16/7/66
B300201628296 ( Other Identifier: Belgian Registration )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ethisch Comité, UZA, University Hospital, Antwerp:
vaginal, yeast infection, candida, candidosis

Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases