BACKGROUND: This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag  ) containing three Lactobacillus strains together with standard @entity868 treatment and also targeted antibiotic treatment (following the failure of @entity868 therapy) could reduce the recurrence rates of @entity6981 (AV). METHODS: @entity1 at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive @entity868 and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5-6 (I, II, II bis - if applicable, III, IV, V). One probiotic or placebo capsule was administered with @entity868 /targeted antibiotic twice daily for 10  days; during follow up, @entity1 took one capsule daily for 10  days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n   =   285; placebo, n   =   293) 18-50-year-old @entity1 who were randomised. RESULTS: BV/AV was confirmed microbiologically in 241 (probiotic, n   =   118; placebo, n   =   123) @entity1 , who continued the trial. Data from 154 (probiotic, n   =   73; placebo, n   =   81) @entity1 who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n   =   22; placebo, n   =   15) @entity1 who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51  % (p   <   0.05) compared with placebo; AV relapse was delayed by up to 76  % (p   <   0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment. CONCLUSION: This study demonstrated that oral probiotics lengthened remission in @entity1 with recurrent BV/AV and improved clinical and microbiological parameters. TRIAL REGISTRATION: NCT01993524 ; 20 November 2013.

Supplementation of standard antibiotic therapy with oral probiotics for XXXX : a randomised, double-blind, placebo-controlled trial.

@entity1 :: ('9606', 'Species') :: ['participants', 'women', 'Patients', 'patients'] @entity868 :: ('MESH:D008795', 'Chemical') :: ['metronidazole'] @entity6981 :: ('MESH:D016585', 'Disease') :: ['bacterial vaginosis (BV) and aerobic vaginitis']
@entity6981 :: (MESH:D016585,Disease) :: ['bacterial vaginosis and aerobic vaginitis']
