BV is one of the most frequent vaginal infections and if left untreated may have severe gynaecological and obstetric consequences such as pelvic inflammatory disease, miscarriage and preterm delivery (2). Even if BV is successfully cured with commonly used antibiotics, the recurrence rate has been reported as high as 80% after nine months (3).
The study involved 100 women diagnosed with BV. All women were given a standard antibiotic treatment with Clindamycin vaginal cream (Dalacin). On a randomised basis, half of the cured women were treated with one EcoVag vaginal capsule and the other half with an identical placebo capsule per day for 10 days during three consecutive menstrual cycles to measure the impact on recurrent infection rates.
The study shows that the recurrent BV infection rate is significantly reduced for the women taking EcoVag. At the study completion, after six months 65% of the EcoVag treated women were still BVfree compared to 46% of the placebo-treated women (p<0.05).
Comparison of the two groups regarding "time from cure to relapse" was also statistically significant (p<0.05).
Furthermore, the study also confirmed that EcoVag is safe to use.
The study was performed in accordance with GCP/ICH in Drammen, Norway by Principal investigator Assistant Professor, MD, PhD, Dr Per- Göran Larsson; "Too many women suffer from chronic or frequent recurring vaginal infections. The study shows that this particular probiotic product can reduce the risk of recurrent infections, and substantiates the potential of vaginal applied probiotics to positively influence urogenital health" says Dr. Per-Göran Larsson.
Erik Brandsborg, Director of Research & Development at Bifodan: "The results of the study are a very important milestone and corroborates with findings from in-vitro tests and several in-vivo pilot studies performed with the product. Summarizing the results from these trials, EcoVag is safe to use, can prevent women from getting recurrent BV infections and can offer relief to the many women who suffer from BV associated symptoms like itching and burning.
Since 1992, Bifodan has specialized in the development and supply of customized and innovative probiotic solutions for the pharmaceutical and dietary supplement industries. Based on years of specialized experience within formulation and manufacturing of probiotics, Bifodan has introduced a portfolio of unique probiotic concepts, under the EcoVag and Bifolac brand names, targeting women's health and gastrointestinal health. Bifodan maintains state of the art manufacturing facilities dedicated to probiotic manufacturing under pharmaceutical GMP conditions.
1) Larsson P, Stray-Pedersen B, Ryttig KR, Larsen S. Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a six-month, double blind, randomised, placebocontrolled study. BMC Women's Health 2008, doi:10.1186/1472-6874-8-3
2) Larsson PG, Bergstrom M, Forsum U, Jacobsson B, Strand A, Wolner- Hanssen P. Bacterial vaginosis. Transmission, role in genital tract infection and pregnancy outcome: an enigma. Apmis 2005;113:233-45.
3) Sobel JD, Ferris D, Schwebke J, Nyirjesy P, Wiesenfeld HC, Peipert J, Soper D, Ohmit SE, Hillier SL.. Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial Vaginosis. Am J Obstet Gynecol 2006;194:1283-9.
