Comparing medical grade honey to Fluconazole for treating recurrent vaginal yeast infections
A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
This study is testing whether a special medical grade honey can work as well as Fluconazole to treat women with recurring vaginal yeast infections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 2 sites (Heerlen and 1 other locations) |
| Trial ID | NCT05367089 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a medical grade honey formulation (L-Mesitran) compared to Fluconazole in treating recurrent vulvovaginal candidiasis. Participants will undergo vaginal swabs to assess the presence of Candida after one month of treatment, with follow-ups at six and twelve months to monitor symptoms and potential relapses. The study will also collect data on side effects, discomfort, and quality of life to provide a comprehensive understanding of treatment outcomes. A total of 252 patients will be included in the study.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a history of recurrent vulvovaginal candidiasis.
Not a fit: Patients with mixed vaginal infections, those who are pregnant or breastfeeding, or those with known allergies to Fluconazole or honey may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, effective treatment option for women suffering from recurrent vulvovaginal candidiasis.
How similar studies have performed: While the use of medical grade honey in treating infections is promising, this specific comparison with Fluconazole is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heerlen and 1 other locations
- Zuyderland Medical Centre — Heerlen, Netherlands (Recruiting)
- MaastrichtUMC — Maastricht, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.