Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses

Abstract

Background: The primary objective of this study was to investigate if extended antibiotic treatment against bacterial vaginosis (BV) together with adjuvant lactobacilli treatment could cure BV and, furthermore, to investigate factors that could cause relapse.

Methods: In all, 63 consecutive women with bacterial vaginosis diagnosed by Amsel criteria were offered a much more aggressive treatment of BV than used in normal clinical practice with repeated antibiotic treatment with clindamycin and metronidazole together with vaginal gelatine capsules containing different strains of lactobacilli both newly characterised and a commercial one (109 freeze-dried bacteria per capsule). Oral clindamycin treatment was also given to the patient's sexual partner.

Results: The cure rate was 74.6% after 6 months. The patients were then followed as long as possible or until a relapse. The cure rate was 65.1% at 12 months and 55.6% after 24 months. There was no significant difference in cure rate depending on which Lactobacillus strains were given to the women or if the women were colonised by lactobacilli. The most striking factor was a new sex partner during the follow up period where the Odds Ratio of having a relapse was 9.3 (2.8-31.2) if the patients had a new sex partner during the observation period.

Conclusions: The study shows that aggressive treatment of the patient with antibiotics combined with specific Lactobacillus strain administration and partner treatment can provide long lasting cure. A striking result of our study is that change of partner is strongly associated with relapse of BV.

Trial registration: ClinicalTrials.gov: NCT01245322.

Figure 1

Time schedule of the treatment and follow up. Even if the patient had a relapse at the self taken samples (3-6 months) she did not receive treatment until the clinical visit that determined with Amsel criteria at the clinical visit after 6 months.

Figure 2

Survival analysis with Life table showing the difference in cure rate between vaginal and oral administration of different Lactobacillus preparations. No statistical difference is seen. Group 0: EcoVag^® capsule containing L. gasseri DSM 14869 and L. rhamnosus DSM 14870; Group 1: L. crispatus 4R5, L. gasseri 20M39, and L. jenseneii 22B42; Group 2: L. crispatus 23B33, L. gasseri 6M9, L. jenseneii 12B1; Group 3: L. crispatus 21M49, L. gasseri 6M9 and L. crispatus 8R6; Group 4: L. gasseri DSM 14869, L. rhamnosus DSM 14870 and L. gasseri DSM 15527; Group 5: Oral (the same group as the vaginal group 4) L. gasseri DSM 14869, L. rhamnosus DSM 14870, L. gasseri DSM 15527; Group 6: oral LaciBios^® femina containing L. rhamnosus GR-1 and L. reuteri RC-14.

Figure 3

Survival analysis with Kaplan-Meier showing that there were significantly more relapses in patients who report a new sexual partner during follow up. Log rank < 0.001. Patients that are censored means that they have not completed the 24-month follow up. For some women the 24-month follow up is not done until 30 month. That is why some patients are reported as 30 month.