A randomized controled trial: the effect of a medical grade honey formulation (L-Mesitran®) on clinical symptoms of recurrent vulvovaginal candidiasis

Recruiting

Conditions: Vaginale infectie
Recurrent vaginal fungal infection/ Recurrent vulvovaginal candidiasis
10017528

Registration Number: NL-OMON54302

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 252

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Mixed vaginal infections
• Pregnancy or the intention to become pregnant during the study period
• Women using systemic or topical antifungal medication during the last two
weeks prior to inclusion
• Known allergies or containdications for Fluconazole or honey
• Candida with resistance for Fluconazole
• Women giving breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the vaginal culture after one month of therapy for<br /><br>both the treatment (L-Mesitran®) and control (Diflucan®) groups. Since the<br /><br>number of relapses is important for investigating the long-term efficacy, the<br /><br>follow-up period will be 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to investigate the effects of both treatments on<br /><br>the clinical symptoms, including redness, irritation, itching, dysuria,<br /><br>dyspareunia, vaginal discharge after 1, 6, 9, and 12 months of therapy. In<br /><br>addition, the prophylactic activity after 6 months maintenance therapy, and the<br /><br>long-term efficacy as number of relapses within 12 months will be investigated.<br /><br>Moreover, information about side effects, discomfort, quality of life, therapy<br /><br>compliance, and cost of treatments for both products will be collected and<br /><br>compared. Furthermore, we will analyze the vaginal microbiota (by vaginal<br /><br>self-swabs) to study the effect of MGH on the vaginal microenvironment. </p><br>