Clinical trial NCT05367089: The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Official title: A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Candidiasis, Vulvovaginal
Recurrent Candidiasis of Vagina
Keywords: L-Mesitran
Fluconazol
vaginal swabs
medical grade honey
antifungal activity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Zuyderland Medical Centre
First posted: 2022-05-10
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.

Detailed description: The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.

Eligibility criteria: Inclusion Criteria:

* Women of at least 18 years old
* Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
* Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
* Capacity to understand, consent, and comply with the trial procedures

Exclusion Criteria:

* Mixed vaginal infections
* Pregnancy or the intention to become pregnant during the study period
* Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
* Known allergies or contra-indications for Fluconazole or honey
* Candida with resistance for Fluconazole
* Women giving breastfeeding

Primary outcomes:
measure: vaginal swab
timeFrame: 1 month
measure: vaginal swab
timeFrame: 6 months
measure: vaginal swab
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life will be determined with questionnaires
timeFrame: 1 month
measure: Quality of life will be determined with questionnaires
timeFrame: 6 months
measure: Quality of life will be determined with questionnaires
timeFrame: 9 months
measure: Quality of life will be determined with questionnaires
timeFrame: 12 months
measure: Side effects of medication will be determined with questionnaires
timeFrame: 1 month
measure: Side effects of medication will be determined with questionnaires
timeFrame: 6 months
measure: Side effects of medication will be determined with questionnaires
timeFrame: 9 months
measure: Side effects of medication will be determined with questionnaires
timeFrame: 12 months
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
Study officials:
References: