Randomised clinical trial in women with Recurrent Vulvovaginal Candidiasis: Efficacy of probiotics and lactoferrin as maintenance treatment

Abstract

Summary Background Vulvovaginal candidiasis (VVC) is a recurrent vaginal condition in childbearing women. Objectives The aim of this study was to assess the efficacy of an oral formulation containing Lactobacillus acidophilus GLA‐14, Lactobacillus rhamnosus HN001 and bovine lactoferrin on symptoms and recurrence of VVC as adjuvant therapy to topical clotrimazole. Patients/Methods Forty‐eight women positive for C. albicans, symptoms of VVC and documented history of recurrences were randomised into 2 groups receiving verum or placebo (2 capsules/day for 5 days followed by 1 capsule/day for additional 10 days) as adjuvant treatment to clotrimazole (induction phase) followed by a maintenance cycle of 6 months (1 capsule/day verum or placebo for 10 consecutive days each month). Symptoms, overall cure rate and recurrence rate were assessed. Results After clotrimazole therapy, a significant improvement of symptoms was shown in both groups. However, only women treated with probiotics and lactoferrin showed a significant improvement of itching and discharge at 3 and 6 months. During the six‐month follow‐up, recurrences were significantly less in the intervention group vs placebo (33.3% vs 91.7% after 3 months and 29.2% vs 100% after 6 months). Conclusions The results show that the investigated lactobacilli mixture in combination with lactoferrin represents a safe and effective adjuvant approach for reducing symptoms and recurrences of RVVC.

Guideline: Vulvovaginal candidosis (AWMF 015/072, level S2k)

“…Due to the antagonistic effect of some lactobacilli in Candida ‐induced vulvovaginitis, probiotics are considered a natural approach for the prevention and treatment of vaginal infections. Extragenital sites, such as the intestine, serve as a reservoir for recolonisation in women with chronic RVVC, 209 so that oral probiotics may also be considered in women with chronic RVVC and those with a contraindication to antifungal therapy 8,210 …”

Vaginal microbiota and the potential of Lactobacillus derivatives in maintaining vaginal health

“…Meanwhile, the usage of lactobacilli could also reduce the rate of VVC recurrence. For instance, oral co-administration of clotrimazole and oral capsule (containing L. acidophilus GLA-14 and L. rhamnosus HN001) with bovine lactoferrin RCX were shown to significantly reduce VVC recurrence by 58.4% and 70.8%, respectively at three and six months as compared to non-lactobacilli administration control group [ 173 ]. It is imperative that the restoration of vaginal microbiota could prevent various vaginal infections and the rate of its recurrence.…”

The Impact of Lactoferrin on the Growth of Intestinal Inhabitant Bacteria

“…Recombinant Lactobacillus strains expressing Lf [126,127] may be future strategies to prevent and combat high-risk human infections, such as neonatal necrotizing enterocolitis [128]. As documented in murine models and clinical trials, pharmaceutical preparations containing bLf and probiotics or Lf-producing probiotic strains have been effective to combat vulvovaginal infections caused Candida albicans , Gardnerella vaginalis, or Atopobium vaginalis by restoring the microbiota in vulvovaginal tract [129,130,131]. These findings provide promising insights to control vulvovaginal infections caused resistant pathogens via microbiota modulation.…”