Around three quarters of women develop vaginal yeast infections at least once in their lifetime, and approximately 140 million women globally suffer from recurrent infections. Recurrent yeast infections can have an enormous impact of quality of life. Existing anti-fungal treatments are not always effective and resistance against these treatments is developing.

Vaginal yeast infection is caused by a yeast called Candida. There are a number of species of Candida, but the one that causes most yeast infections is Candida albicans.

New research led by the University of Exeter’s MRC Centre for Medical Mycology has found that the trace mineral zinc could play a surprising role. Just like us, Candida albicans needs zinc in its diet and this yeast produces a molecule (Pra1) which tries to scavenge zinc as a food source. Now, researchers have found that this molecule triggers an inflammatory response, which they believe is responsible for many cases of yeast infection.

Wellcome Trust Senior Fellow Dr Duncan Wilson, of the University of Exeter’s MRC Centre for Medical Mycology, led the research, and said: “Recurring thrush can be deeply distressing and problematic, and we urgently need new treatments. Our new finding on zinc is very exciting, because it suggests that simple provision of zinc could block the production of the inflammatory Pra1 molecule, but we’re not in the position to make treatment recommendations at this stage. We need larger scale trials to confirm the effect. Please don’t apply any products that are not designed for the genital area, as zinc can be toxic at high concentrations and it could be extremely unsafe.”
In lab experiments, the team found that manipulating genes so that Candida albicans does not produce Pra1 prevented inflammation. In the paper, published in Science Translational Medicine, they went on to find that applying relatively low levels of zinc in mice blocked Pra1 production, and prevented inflammation. This is important because it is inflammation that causes the burning and itching symptoms of yeast infection.

Fempharma’s CEO Dr Peter Bartal said: “We are now carrying out a large clinical trial to confirm that JUVIAGEL zinc treatments are effective. We believe that we can develop our product to help avoid the recurrence of vaginal yeast infections.”

The aim of this clinical trial is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). Our hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

Our randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc-containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4-8-12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow-ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in-office evaluation.

Efficacy measurements will include collection of clinical signs (erythema, edema, excoriation) and symptoms (itching, burning, irritation) of vulvovaginitis using a scoring scale of 0–3 (0 = none, 1 = mild, 2 = moderate, 3 = severe) for each sign or symptom to give a total severity score of 0–18 [Sober et al]. In addition, a KOH wet mount test, vaginal fungal culture and cervicovaginal lavage (CVL) will be performed at each visit.

Primary outcome: The proportion of participants with clinical cure throughout the study period. Clinical cure was defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period.