Gynecology & Obstetrics
Open Access
ISSN: 2161-0932
ISSN: 2161-0932
Andreas Schwiertz, Marina Knauf, Ute Pohl, Brunhilde Hackel and Hans-Jorg Mueller
Objective: Aim of this clinical study was the evaluation of the medical device SymbioVag® on bacterial vaginosis (BV) and its tolerability
Method: An open-label study was conducted on 103 female subjects aged 18 to 56 years with manifested BV. Enrolled subjects were treated for 10 successive days with the synbiotic vaginal suppository SymbioVag® containing Lactobacillus acidophilus, Lactobacillus gasseri in combination with the prebiotic substance inulin BV was diagnosed using the Amsel criteria. In addition, bacterial counts of lactobacilli, Gardnerella vaginalis, Atopobium vaginae and total anaerobes were detected. Symptoms associated with bacterial vaginosis were rated by the patients before and after the use of SymbioVag®
Results: Treatment with SymbioVag® reduced vaginal pH in more than 80% of the patients. The concentration of lactobacilli increased significantly. A decrease in pathogen organisms was observed in nearly 60% of the patients for both marker organisms, G vaginalis and A vaginae, as well as for one out of four measured anaerobes 80-90% of the patients rated the symptoms associated with bacterial vaginosis as being improved. Microscopic examination and test for the presence of amines showed an improvement in more than half of the patients. The evaluation of tolerability, together with the observed adverse events, attests the very good safety profile of the vaginal suppository.
Conclusion: The presented study showed that the synbiotic vaginal suppository, a combination of Lactobacillus acidophilus, Lactobacillus gasseri and the prebiotic substance inulin, is well tolerated, and confirms a general improvement of symptoms, a decrease in vaginal pH, and an improvement of the vaginal flora Hence, the trial provides clear evidence for the justification of SymbioVag® being applied in patients suffering from bacterial vaginosis.