J M Bohbot1, E Daraï2, F Bretelle3, G Brami4, C Daniel5, J M Cardot6. 1. Institut Alfred-Fournier, 75014 Paris, France. 2. Service de gynécologie-obstétrique et médecine de la reproduction, hôpital Tenon, université Pierre-et-Marie-Curie, UMRS 938, AP-HP, 75020 Paris, France. 3. Department of gynaecology and obstetrics, gynépole, AMU, Aix-Marseille université, UM63, CNRS 7278, IRD 198, Inserm 1095, Assistance publique-Hôpitaux de Marseille, 13005 Marseille, France. 4. Laboratoires IPRAD PHARMA, 174, quai de Jemmapes, 75010 Paris, France. Electronic address: g.brami@iprad.com. 5. Laboratoires IPRAD PHARMA, 174, quai de Jemmapes, 75010 Paris, France. 6. Université Clermont-Auvergne, UMR MEDIS, CHU de Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Abstract
BACKGROUND:Bacterial vaginosis (BV) is a recurrent disease in women despite treatment by antibiotics. This study investigated the impact of a vaginal probiotic, Lactobacillus crispatus IP174178* (Lc), on the rate of recurrence and time to recurrence. METHODS: A prospective, multi-centre, double blind, randomised phase III trial in women with at least two documented episodes of BV in the previous year (diagnosis confirmed by presence of three Amsel criteria and a Nugent score≥7), and who had been clinically cured (i.e., no Amsel criteria) after oral metronidazole treatment (1g/day×7 days). The patients were randomised to receive vaginal capsules of either Lc or placebo, once a day, for 14 days over the first two menstrual cycles and another 14 days of the same treatment for the following two menstrual cycles. The primary efficacy endpoint was the number of patients with at least one bacteriologically confirmed recurrence of BV. RESULTS: Out of 98 assessable patients (mean age 35.7 years), 78 women were evaluated (20 patients had missing data). During the treatment period, 16/39 patients (41%) had at least one recurrence in the placebo group versus 8/39 patients (20.5%) in the Lc group (P=0.0497). The time to recurrence was longer by 28% in the Lc group (3.75±0.16 months) vs. the placebo group (2.93±0.18 months) (P=0.0298). Tolerability and safety were good in both groups. CONCLUSION: In women with recurrent BV after antibiotics, treatment with Lc IP 174178 administered over four menstrual cycles, could significantly reduce the rate of recurrence and increase the time to recurrence.
RCT Entities:
BACKGROUND:Bacterial vaginosis (BV) is a recurrent disease in women despite treatment by antibiotics. This study investigated the impact of a vaginal probiotic, Lactobacillus crispatus IP174178* (Lc), on the rate of recurrence and time to recurrence. METHODS: A prospective, multi-centre, double blind, randomised phase III trial in women with at least two documented episodes of BV in the previous year (diagnosis confirmed by presence of three Amsel criteria and a Nugent score≥7), and who had been clinically cured (i.e., no Amsel criteria) after oral metronidazole treatment (1g/day×7 days). The patients were randomised to receive vaginal capsules of either Lc or placebo, once a day, for 14 days over the first two menstrual cycles and another 14 days of the same treatment for the following two menstrual cycles. The primary efficacy endpoint was the number of patients with at least one bacteriologically confirmed recurrence of BV. RESULTS: Out of 98 assessable patients (mean age 35.7 years), 78 women were evaluated (20 patients had missing data). During the treatment period, 16/39 patients (41%) had at least one recurrence in the placebo group versus 8/39 patients (20.5%) in the Lc group (P=0.0497). The time to recurrence was longer by 28% in the Lc group (3.75±0.16 months) vs. the placebo group (2.93±0.18 months) (P=0.0298). Tolerability and safety were good in both groups. CONCLUSION: In women with recurrent BV after antibiotics, treatment with Lc IP 174178 administered over four menstrual cycles, could significantly reduce the rate of recurrence and increase the time to recurrence.
Authors: Giampaolo Mainini; Mario Passaro; Antonio Schiattarella; Pasquale De Franciscis; Mariano C Di Donna; Gennaro Trezza Journal: Prz Menopauzalny Date: 2020-10-02
Authors: Jack D Sobel; Navkiranjot Kaur; Nicole A Woznicki; Dina Boikov; Tina Aguin; Gurveer Gill; Robert A Akins Journal: Infect Drug Resist Date: 2019-07-24 Impact factor: 4.003