1. Efficacy and safety of vaginally administered lyophilized Lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence
- Author
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Emile Daraï, J.M. Bohbot, Florence Bretelle, G. Brami, C. Daniel, J.M. Cardot, Service de Gynécologie-obstétrique et médecine de la reproduction - Maternité [CHU Tenon], CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Expert en Endométriose [CHU Tenon] (GRC6 C3E), Pathologies biliaires, fibrose et cancer du foie [CRSA], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), CCS SI Patient, Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Laboratoire d'Informatique Médicale et Ingénierie des Connaissances en e-Santé (LIMICS), Université Paris 13 (UP13)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), company IPRAD PHARMA, COMBE, Isabelle, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Groupe de recherche clinique Centre Expert en Endométriose (GRC 6 - C3E), Sorbonne Université (SU), Gynécologie-obstétrique et médecine de la reproduction - Maternité [CHU Tenon], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pathologies biliaires, fibrose et cancer du foie [CHU Saint-Antoine], Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris 13 (UP13)
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Adult ,medicine.medical_specialty ,vagin ,medicine.drug_class ,Antibiotics ,Placebo ,Gastroenterology ,law.invention ,Double blind ,03 medical and health sciences ,Probiotic ,0302 clinical medicine ,Double-Blind Method ,law ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Internal medicine ,Outcome Assessment, Health Care ,Secondary Prevention ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Lactobacillus crispatus ,030219 obstetrics & reproductive medicine ,biology ,business.industry ,Probiotics ,Obstetrics and Gynecology ,Vaginosis, Bacterial ,medicine.disease ,biology.organism_classification ,probiotique ,3. Good health ,Surgery ,lactobacillus ,Administration, Intravaginal ,Metronidazole ,antiprotozoaire ,Reproductive Medicine ,Tolerability ,[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Female ,Bacterial vaginosis ,business ,medicine.drug - Abstract
Erratum to: “Efficacy and safety of vaginally administered lyophilized Lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence” [J. Gynecol. Obstet. Hum. Reprod. 47 (2018) 81–7]; International audience; 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 (1 g/day x 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. (C) 2017 Published by Elsevier Masson SAS.
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- 2018
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