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Managing women’s health conditions with a clinically validated probiotic

Vulvovaginal infections are the most frequent request for gynecological consultation. In this broad spectrum of situations, yeast infection from Candida​ species and bacterial vaginosis from anaerobic bacteria are among the most common vaginal infections. Women need better ways to manage bacterial vaginosis and vulvovaginal candidiasis. While multiple treatments for the common vaginal infections exist, they suffer from high relapse rates that create a need for new interventions that prevent recurrent infections. Giellepi is addressing the unmet need with RESPECTA, an oral probiotic that is clinically proven to reduce symptomatic recurrences.

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The scale of the unmet need is starkly illustrated by data on the epidemiology of bacterial vaginosis and vulvovaginal candidiasis. Bacterial vaginosis is the most common vaginal infection in reproductive-age women, with estimates of the proportion of individuals affected running to as high as 70%.1​ Vulvovaginal candidiasis, a fungal infection, affects around three-quarters of women during their reproductive years.2

Physicians use antibiotics such as clindamycin or metronidazole and antifungals including fluconazole or clotrimazole to treat the two infections. Short courses of anti-infectives are used to treat acute, uncomplicated cases while long or repetitive courses of drugs are prescribed to reduce the risk of recurrent infections.3,​4

The high relapse rates have resulted in a population of women who suffer from recurrent bacterial vaginosis and vulvovaginal candidiasis, health conditions known respectively by the initialisms RBV and RVVC and defined as at least 3 or 4 episodes of symptomatic vulvovaginal infection in the last 12 months.5,6

Recurrent infections are a problem. RBV is associated with miscarriage, preterm birth and increased risk of acquiring HIV.7​ RVVC causes vaginitis and symptoms such as itching and soreness that are detrimental to quality of life. Maintenance therapy can temporarily prevent the recurrence of symptoms but 30% to 50% of women suffer vulvovaginal candidiasis again after stopping treatment.3,​4​ In case of recurrent fungal condition, weekly oral fluconazole doses should be used for six months. In fact, one study found 72% of women relapsed within six months of successful fluconazole treatment for vulvovaginal candidiasis.6

Bacterial vaginosis recurred in 58% of women within 12 months of treatment with oral metronidazole therapy ​and for this reason weekly or monthly antibiotic treatment is needed ​in case of RBV to reduce symptoms of relapse.5​ Equally, long-term use of antibiotics and antifungals to treat RBV and RVVC is undesirable because it raises the risk of drug resistance and has negative implications for the gut and vaginal flora. A way of preventing recurrence without resorting to weekly doses of anti-infectives is needed.

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Correcting vaginal dysbiosis

Recognition that bacterial vaginosis and vulvovaginal candidiasis are driven by the dysbiosis of the vaginal microbiota has led to the marketing of probiotic treatments for the conditions. However, while there is a plausible mechanism of action for using probiotics to treat and manage RBV and RVVC, few companies have invested in the clinical trials needed to validate the concept in humans.

Giellepi has clinically validated its products, including its proprietary probiotic combination RESPECTA. The oral capsules consist of Lactobacillus acidophilus​ LMG S29159, Lactobacillus rhamnosus ​ATCC SD5675 and lactoferrin. Giellepi included 5 billion colony forming units of the lactobacilli bacteria in light of evidence of the pivotal role they play in the first line of defense in the female genital tract by inhibiting the growth of potentially pathogenic microorganisms.

The inclusion of lactoferrin, which sets RESPECTA apart from other lactobacilli probiotics, is based on evidence that it strongly affects the growth and diversity of intestinal microbiota. Research shows the

iron-binding milk glycoprotein lactoferrin inhibits the growth of a wide range of pathogenic bacteria while aiding the expansion of gut-beneficial microorganisms such as lactobacilli and bifidobacteria.

Giellepi hypothesized that combining its two lactobacilli bacteria with lactoferrin would restore the genital tract to a healthy condition by reducing levels of pro-inflammatory cytokines and increasing numbers of gut-beneficial microorganisms. Reflecting its scientific ethos, Giellepi put its hypothesis to the test in a series of clinical trials.

 

Validating the probiotic in humans

Giellepi initially showed oral doses of RESPECTA colonize the vaginal microbiota in healthy women.8​ Having shown RESPECTA gets lactobacilli to the target site, Giellepi ran a placebo-controlled trial in women with unbalanced flora.9​ The trial linked use of RESPECTA for 15 days to changes in the Nugent score used to diagnose bacterial vaginosis. Scores in the RESPECTA arm went from intermediate to healthy. Women also reported significant improvements in vaginal symptoms such as itching and discharge.

Subsequent studies in RBV and RVVC provided further evidence of the efficacy of RESPECTA in the management of recurrent infections. One placebo-controlled trial assessed RESPECTA as an adjuvant therapy to metronidazole in women with RBV.10​ The 48-subject trial linked the use of RESPECTA to significant reductions in vaginal malodorous discharge and lower pH values (acid physiological pH) versus placebo after four and six months.    

The overall cure rate was significantly higher in the RESPECTA arm from two weeks through to the end of the six-month study. Recurrence was rarer in the RESPECTA cohort, too. Over six months, 29% of women treated with RESPECTA experienced a recurrence, compared to 58% of people in the placebo group. Seventy-one percent of women on RESPECTA remained free from bacterial vaginosis.

Another trial showed RESPECTA is similarly efficacious in RVVC.11​ All 48 women, who had symptomatic acute episodes of vulvovaginal candidiasis and a history of recurrences, received clotrimazole during the induction phase, after which they took either placebo or RESPECTA for six months. The trial linked RESPECTA to significant improvements in the cure rate and vaginal itching at three and six months. Recurrence was significantly lower in the RESPECTA arm at three and six months.

 

Building a women’s health portfolio

The series of clinical trials have established RESPECTA as a tailored probiotic supplementation strategy that is clinically proven to reduce symptomatic recurrences. Through the trials, Giellepi showed that RESPECTA capsules only need to be taken once a day for 10 days each month to reduce the chances of bacterial vaginosis and vulvovaginal candidiasis recurring.

RESPECTA capsules are part of a portfolio of clinically validated women’s health products that Giellepi has created for private label distributors worldwide. The capsules are complemented by RESPECTA Balance Gel and RESPECTA Hydra Gel, medical devices for topical use that respectively rebalance the physiological pH and vaginal microbiota and provide moisturizing and lubricant action.

By developing and validating the RESPECTA portfolio, Giellepi has created a line of clinically proven products that address the unmet needs faced by women with bacterial vaginosis and vulvovaginal candidiasis. Private label distributors that work with Giellepi to get the RESPECTA products to women stand to alleviate the unmet need and unlock commercial opportunities.

 

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References

1.     Kairys, N. & Garg, M. Bacterial Vaginosis. in StatPearls​ (StatPearls Publishing, 2021).

2.     Dovnik, A., Golle, A., Novak, D., Arko, D. & Takač, I. Treatment of vulvovaginal candidiasis: a review of the literature. Acta Dermatovenerol Alp Pannonica Adriat​ 24​, 5–7 (2015).

3.     Vulvovaginal Candidiasis. https://www.cdc.gov/std/tg2015/candidiasis.htm (2019).

4.     Bacterial Vaginosis. https://www.cdc.gov/std/tg2015/bv.htm (2020).

5.     Bradshaw, C. S. et al.​ High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J. Infect. Dis.​ 193​, 1478–1486 (2006).

6.     Sobel, J. D. et al.​ Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N. Engl. J. Med.​ 351​, 876–883 (2004).

7.     Lambert, J. A., John, S., Sobel, J. D. & Akins, R. A. Longitudinal analysis of vaginal microbiome dynamics in women with recurrent bacterial vaginosis: recognition of the conversion process. PLoS One​ 8​, e82599 (2013).

8.     De Alberti, D., Russo, R., Terruzzi, F., Nobile, V. & Ouwehand, A. C. Lactobacilli vaginal colonisation after oral consumption of Respecta(®) complex: a randomised controlled pilot study. Arch. Gynecol. Obstet.​ 292​, 861–867 (2015).

9.     Russo, R., Edu, A. & De Seta, F. Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. Arch. Gynecol. Obstet.​ 298​, 139–145 (2018).

10.   Russo, R., Karadja, E. & De Seta, F. Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomised clinical trial. Beneficial Microbes​ vol. 10 19–26 (2019).

11.   Russo, R., Superti, F., Karadja, E. & De Seta, F. Randomised clinical trial in women with Recurrent Vulvovaginal Candidiasis: Efficacy of probiotics and lactoferrin as maintenance treatment. Mycoses​ 62​, 328–335 (2019).

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