Nucleic acid-based diagnosis of bacterial vaginosis and improved management using probiotic lactobacilli. Improved cure of bacterial vaginosis with single dose of tinidazole (2 g), Lactobacillus rhamnosus GR-1, and Lactobacillus reuteri RC-14: a randomized, double-blind, placebo-controlled trial. Clinical study comparing probiotic Lactobacillus GR-1 and RC-14 with metronidazole vaginal gel to treat symptomatic bacterial vaginosis. Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 to prevent or cure bacterial vaginosis among women with HIV. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Effectiveness of the Two Microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, Formulated in Slow-release Vaginal Tablets, in Women Affected by Bacterial Vaginosis: A Pilot Study Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-Controlled Double-Blind Trial The use of Lactobacillus rhamnosus in the therapy of bacterial vaginosis. Evaluation of clinical efficacy in a population of 40 women treated for 24 months Probiotic Lactobacillus dose required to restore and maintain a normal vaginal flora. Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria Oral use of Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 significantly alters vaginal flora: randomized, placebo-controlled trial in 64 healthy women. Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. Recurrence of bacterial vaginosis is significantly associated with posttreatment sexual activities and hormonal contraceptive use. Therapy of bacterial vaginosis using exogenously-applied Lactobacilli acidophili and a low dose of estriol: a placebo-controlled multicentric clinical trial. Prospective study of correlates of vaginal Lactobacillus colonisation among high-risk HIV-1 seronegative women Why Do Different Criteria for ‘Cure’ Yield Different Conclusions in Comparing Two Treatments for Bacterial Vaginosis? Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel. Women's satisfaction with an intravaginal Lactobacillus capsule for the treatment of bacterial vaginosis. Topical Penile Microbicide Use by Men to Prevent Recurrent Bacterial Vaginosis in Sex Partners: A Randomized Clinical Trial
Bacterial vaginosis ( BV ) is a common condition in women that represents an imbalance of the vaginal microflora , lactobacilli depletion , and excess growth of mainly anaerobic Gram-negative pathogens . Diagnosis is made using a series of tests or a Gram stain of a vaginal smear . Treatment with antibiotics is quite effective , but recurrences are common . A study of 55 vaginal sample s from 11 postmenopausal women showed the presence of BV by the Gram stain-based Nugent scoring system , and polymerase chain reaction-denaturing gradient gel electrophoresis showed that Bacteroides or Prevotella species were the most common isolates recovered ( 24 of 25 ) , with Escherichia coli , Staphylococcus aureus , and Streptococcus agalactiae also found in some sample s. In one case , only Gardnerella vaginalis was found . These findings illustrate that BV remains common even among otherwise healthy women , but it is not caused solely by either Gardnerella or Mobiluncus . Use of a FemExam system ( Cooper Surgical , Shelton , CT ) , based upon elevated pH and trimethylamine levels , to screen vaginal smears from 59 healthy women showed poor correlation with the Gram stain method . A r and omized , placebo-controlled trial of these subjects showed that the lactobacilli-dominant microbiota was restored in subjects with BV but not in controls , following 2 months of daily oral intake of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 . These studies show that nucleic acid-based methods are effective at identifying bacteria responsible for BV . If such methods could be used to develop a commercially available , self-use kit , women would be much better placed to take control of their own health , for example , using medicinal food or dietary supplement products such as the clinical ly proven probiotic strains L. rhamnosus GR-1 and L. fermentum RC-14 Bacterial vaginosis ( BV ) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli . Antimicrobial therapy is often ineffective . We hypothesized that probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 might provide an adjunct to antimicrobial treatment and improve cure rates .  Sixty-four Brazilian women diagnosed with BV were r and omly assigned to receive a single dose of tinidazole ( 2 g ) supplemented with either 2 placebo capsules or 2 capsules containing L. rhamnosus GR-1 and L. reuteri RC-14 every morning for the following 4 weeks . At the end of treatment ( day 28 ) , the probiotic group had a significantly higher cure rate of BV ( 87.5 % ) than the placebo group ( 50.0 % ) ( p = 0.001 ) . In addition , according to the Gram-stain Nugent score , more women were assessed with " normal " vaginal microbiota in the probiotic group ( 75.0 % vs. 34.4 % in the placebo group ; p = 0.011 ) . This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition Bacterial vaginosis ( BV ) is particularly common in black women , and in Nigeria it is often caused by Mycoplasma , as well as Atopobium , Prevotella and Gardnerella sp. Antimicrobial metronidazole oral therapy is poorly effective in eradicating the condition and restoring the Lactobacillus microbiota in the vagina . In this study , 40 women diagnosed with BV by discharge , fishy odor , sialidase positive test and Nugent Gram stain scoring , were r and omized to receive either two dried capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each night for 5 days , or 0.75 % metronidazole gel , applied vaginally twice a day ( in the morning and evening ) . Follow-up at day 6 , 15 and 30 showed cure of BV in significantly more probiotic treated subjects ( 16 , 17 and 18/20 , respectively ) compared to metronidazole treatment ( 9 , 9 and 11/20 : P=0.016 at day 6 , P=0.002 at day 15 and P=0.056 at day 30 ) . This is the first report of an effective ( 90 % ) cure of BV using probiotic lactobacilli . Given the correlation between BV and HIV , and the high risk of the latter in Nigeria , intravaginal use of lactobacilli could provide women with a self-use therapy , similar to over-the-counter anti-yeast medication , for treatment of urogenital infections OBJECTIVE To assess , among women with HIV , whether long-term oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 supplementation can prevent bacterial vaginosis ( BV ) and enhance the cure rate of metronidazole  among those with BV . METHODS A r and omized , double-blind , placebo-controlled trial conducted among 65 HIV-infected women with an aberrant microbiota ( Nugent score 4 - 10 ) who were r and omized to receive daily probiotics or placebo for 6 months . Those with BV ( Nugent score 7 - 10 ) additionally received metronidazole for 10 days ( 400 mg twice daily ) . RESULTS We did not find an enhanced cure rate of BV among women with HIV treated with adjuvant probiotics to metronidazole treatment . Among women with an intermediate vaginal flora , probiotics tended to increase the probability of a normal vaginal flora ( odds ratio 2.4 ; P=0.1 ) and significantly increased the probability of a beneficial vaginal pH ( odds ratio 3.8 ; P=0.02 ) at follow-up . CONCLUSION Supplementation of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 did not enhance the cure of BV among women living with HIV , but may prevent the condition among this population . TRIAL REGISTRATION NCT00536848 This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis ( BV ) by presence of vaginal irritation , discharge and ' fishy ' odor , and Nugent criteria and detection of sialidase enzyme . The subjects were treated with oral metronidazole ( 500 mg ) twice daily from days 1 to 7 , and r and omized to receive oral Lactobacillus rhamnosus GR-1 ( 1 x 10(9 ) ) and Lactobacillus reuteri RC-14 ( 1 x 10(9 ) ) or placebo twice daily from days 1 to 30 . Primary outcome was cure of BV as determined by normal Nugent score , negative sialidase test and no symptoms or signs of BV at day 30 . A total of 106 subjects returned for 30-day follow-up , of which 88 % were cured in the antibiotic/probiotic group compared to 40 % in the antibiotic/placebo group ( p<0.001 ) . Of the remaining subjects , 30 % subjects in the placebo group and none in the probiotic group had BV , while 30 % in the placebo and 12 % in the probiotic group fell into the intermediate category based upon Nugent score , sialidase result and clinical findings . High counts of Lactobacillus sp. ( > 10(5 ) CFU/ml ) were recovered from the vagina of 96 % probiotic-treated subjects compared to 53 % controls at day 30 . In summary , this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women Background : Bacterial vaginosis ( BV ) is the most common reason for abnormal vaginal discharge in reproductive-age women and one of its most important causative agents is the gram-variable bacterium Gardnerella vaginalis . BV is not accompanied by significant local inflammation , whereas the “ fishy odor ” test is always positive . In contrast , aerobic vaginitis ( AV ) is predominantly associated with Escherichia coli , but Streptococcus agalactiae and Staphylococcus aureus are also involved . St and ard treatment of BV consists of oral or intravaginal antibiotics , although these are unable to spontaneously restore normal flora characterized by a high concentration of lactobacilli . The main limitation is the inability to offer a long-term defensive barrier , thus facilitating relapses and recurrences . This study was undertaken firstly to assess the ability of selected lactobacilli to in vitro antagonize G. vaginalis to determine an association with a strain able to inhibit E. coli , thus identifying a possible use in AV . The second step of the study was to conduct a human pilot trial in women affected by BV using an association of the most promising and active bacteria . Material s and Methods : For this purpose , neutralized supernatants of individual lactobacilli were tested at percentages ranging from 0.5 % to 4 % to determine their ability to hinder the growth of G. vaginalis American Type Culture Collection 10231 . The bacterium that was able to exert the strongest inhibition was subsequently tested with Lactobacillus plantarum LP01 in a human intervention , placebo-controlled , pilot trial involving 34 female subjects ( aged between 18 and 50 , mean 34.7±8.9 , no menopausal women ) diagnosed with BV . The 2 microorganisms Lactobacillus fermentum LF15 ( DSM 26955 ) and L. plantarum LP01 ( LMG P-21021 ) were delivered to the vagina by means of slow-release vaginal tablets , also containing 50 mg of tara gum . The amount of each strain was 400 million live cells per dose . The women were instructed to apply a vaginal tablet once a day for 7 consecutive nights , followed by 1 tablet every 3 nights for a further 3-week application ( acute phase ) and , finally , 1 tablet per week to maintain a long-term vaginal colonization against possible recurrences . A clinical examination was performed and the Nugent score was quantified for each patient at enrollment ( d0 ) , after 28 days ( d28 ) , and at the end of the second month of relapse prevention ( d56 ) . A statistical comparison was made between d28 , or d56 , and d0 , and between d56 and d28 to quantify the efficacy against possible recurrences . Results : L. fermentum LF15 showed the strongest in vitro inhibitory activity towards G. vaginalis American Type Culture Collection ( ATCC ) 10231 after both 24 and 48 hours . In the human trial , the 2 lactobacilli selected , namely L. fermentum LF15 and L. plantarum LP01 , significantly reduced the Nugent score below the threshold of 7 after 28 days in 22 patients of 24 in the active group ( 91.7 % , P<0.001 ) . Eight women ( 33.3 % ) recorded a Nugent score between 4 and 6 , evidence of an intermediate situation , whereas the remaining 14 ( 58.3 % ) showed a score < 4 , therefore suggesting the restoration of physiological vaginal microbiota . At the end of the second month , only 4 women registered a Nugent score > 7 , definable as BV ( 16.7 % , P=0.065 compared with d28 ) . In the placebo group , no significant differences were recorded at any time . Conclusions : BV , also known as vaginal bacteriosis is the most common cause of vaginal infection in women of childbearing age . Furthermore , BV is often asymptomatic as about 50 % of women with this condition have no symptoms at all and the prevalence rate in apparently healthy women is around 10 % . This study suggests the ability of the 2 strains L. fermentum LF15 and L. plantarum LP01 to counteract acute Gardnerella infections effectively and significantly improve the related uncomfortable symptoms in a very high percentage of women . This could be partially attributed to the presence of tara gum , which is able to create a mechanical barrier against Gardnerella on the surface of vaginal mucosa as a primary mechanism . Furthermore , long-term physiological protection seems to be established , thanks to the integration of the 2 lactobacilli into the vaginal microbiota and to their adhesion to the epithelial cells of the mucosa . In the light of the additional in vitro inhibitory activity against E. coli , their prospect i ve use in AV could also prove interesting Abstract The purpose of this study was to evaluate the effectiveness of lactobacilli on vaginal health and proinflammatory cytokines . Sixty-seven patients with bacterial vaginosis ( BV ) , 50 with intermediate flora and 42 with normal vaginal flora were enrolled in this double-blind study . The subjects were r and omized to receive probiotic lactobacilli vaginal tablets ( L. brevis CD2 , L. salivarius subsp . salicinius , L. plantarum ) or the vaginal pH tablet ( active comparator ) . Cervico-vaginal lavage was collected to measure the concentrations of IL-1β , TNFα and IL-6 by ELISA . Neutral sphingomyelinase activity was also quantified in both arms before and after treatment . The probiotic vaginal tablet was well tolerated and no side effects were reported . The study demonstrated a cure rate of nearly 80 % ; i.e. , 32 % of the women could restore normal vaginal flora and 47 % had improved Nugent score , whereas 20 % of the subjects did not clear BV in the first follow-up ( after 8 days treatment ) . The pH tablet containing pH lowering compounds induced resolution of BV and restoration of normal vaginal flora in 74 % and 26 % , respectively . The lactobacilli tablet was found to be better than the pH tablet in preventing BV in healthy subjects . A significant reduction in IL-1β and IL-6 vaginal cytokines was observed after treatment with lactobacilli , while the active comparator did not have any effect on local proinflammatory cytokines . Vaginal neutral sphingomyelinase activity was not modified in either group . Vaginal tablets containing lactobacilli can cure BV and reduce vaginal inflammatory response Background To determine if oral metronidazole ( MTZ-400 mg bid ) with 2 % vaginal clindamycin-cream ( Clind ) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol ( Prob ) reduces 6-month bacterial vaginosis ( BV ) recurrence . Methods Double-blind placebo-controlled parallel-group single-site study with balanced r and omization ( 1∶1∶1 ) conducted at Melbourne Sexual Health Centre , Australia . Participants with symptomatic BV [ Nugent Score ( NS ) = 7–10 or ≥3 Amsel 's criteria and NS = 4–10 ] , were r and omly allocated to MTZ-Clind , MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months . MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days . Primary outcome was BV recurrence ( NS of 7–10 ) on self-collected vaginal-swabs over 6-months . Cumulative BV recurrence rates were compared between groups by Chi-squared statistics . Kaplan-Meier , log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups . Results 450 18–50 year old females were r and omized and 408 ( 91 % ) , equally distributed between groups , provided ≥1 NS post-r and omization and were included in analyses ; 42 ( 9 % ) participants with no post-r and omization data were excluded . Six-month retention rates were 78 % ( n = 351 ) . One-month BV recurrence ( NS 7–10 ) rates were 3.6 % ( 5/140 ) , 6.8 % ( 9/133 ) and 9.6 % ( 13/135 ) in the MTZ-Clind , MTZ-Prob and MTZ-Placebo groups respectively , p = 0.13 . Hazard ratios ( HR ) for BV recurrence at one-month , adjusted for adherence to vaginal therapy , were 0.43 ( 95%CI 0.15–1.22 ) and 0.75 ( 95 % CI 0.32–1.76 ) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively . Cumulative 6-month BV recurrence was 28.2 % ; ( 95%CI 24.0–32.7 % ) with no difference between groups , p = 0.82 ; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac , adjusted for adherence to vaginal therapy were 1.09(95 % CI = 0.70–1.70 ) and 1.03(95 % CI = 0.65–1.63 ) , respectively . No serious adverse events occurred . Conclusion Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin , or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic , does not reduce BV recurrence . Trial Registration ANZCTR.org.au Background Bacterial vaginosis ( BV ) is the most prevalent vaginal disorder in adult women worldwide . A number of clinical studies indicate that re-establishment of the physiological ecosystem by re-colonization of vaginal mucosa by lactobacilli may be an effective therapy for BV both after initial antimicrobial therapy or when given alone . A vaginal pH < 4.5 is considered physiological and its measurement has been reported as an objective parameter , very sensitive to alterations of vaginal microflora and correlated with clinical ly relevant BV . Objective The aims of this work were to assess the effectiveness of a long-term ( 24 months ) intravaginal treatment with Lactobacillus rhamnosus ( NORMOGIN ® ) on the vaginal pH and on the clinical symptoms in a group of 40 women affected by BV diagnosed by the Amsel criteria . Method A prospect i ve open clinical trial was performed in 40 consecutive cases evaluated for B.V. by the Amsel criteria . Results Vaginal pH was above the physiological value of 4.5 in 36 out of 40 patients at the first visit . It returned under 4.5 value in 24/40 and 32/40 women after 12 and 24 months of treatment , respectively . pH values were significantly decreased at 12 month treatment ( P < 0.001 ) and further reduction in pH values was found at 24 months of treatment ( P < 0.02 vs. 12 months ) . The gradual return to a vaginal physiological pH was associated with a reduction of the intensity of symptoms as shown by the decrease in the symptoms score . Conclusions The present study supports the use of pH measurement for sensitive , objective , and simple therapy follow-up in women with BV and shows that long-term administration of vaginal tablets containing Lactobacillus rhamnosus represents an effective and safe treatment for restoring the physiological vaginal pH and controlling BV symptoms Forty-two healthy women were r and omized to receive one of three encapsulated Lactobacillus rhamnosus GR-1 plus Lactobacillus fermentum RC-14 probiotic dosage regimens or L. rhamnosus GG by mouth each day for 28 days . However , the vaginal flora , assessed by Nugent scoring , was only normal in 40 % of the cases , and 14 patients had asymptomatic bacterial vaginosis . Treatment with L. rhamnosus GR-1/L. fermentum RC-14 once and twice daily correlated with a healthy vaginal flora in up to 90 % of patients , and 7/11 patients with bacterial vaginosis converted to normal or intermediate scores within 1 month . Ingestion of L. rhamnosus GG failed to have an effect . This study confirms the potential efficacy of orally administered lactobacilli as a non-chemotherapeutic means to restore and maintain a normal urogenital flora , and shows that over 10(8 ) viable organisms per day is the required dose Background Bacterial vaginosis ( BV ) is a common condition that is associated with preterm birth and acquisition of complex communities of vaginal bacteria that include several fastidious species . Treatment of BV in pregnancy has mixed effects on the risk of preterm delivery , which some hypothesize is due to variable antibiotic efficacy for the fastidious bacteria . Both oral and intravaginal metronidazole can be used to treat bacterial vaginosis in pregnancy , but little is known about the impact of different routes of antibiotic administration on concentrations of fastidious vaginal bacteria . Methods This was a sub- study of a larger r and omized trial of oral versus vaginal metronidazole for treatment of BV in pregnancy . Fifty-three women were evaluated , including 30 women who received oral metronidazole and 23 who received intravaginal metronidazole .  Bacterial taxon-specific quantitative PCR assays were used to measure concentrations of bacterial vaginosis associated bacterium ( BVAB ) 1 , 2 , and 3 , Gardnerella vaginalis , Atopobium species , Leptotrichia/Sneathia species , Megasphaera species , and Lactobacillus crispatus before and after antibiotic treatment . Results Concentrations of Leptotrichia and Sneathia spp . and the fastidious Clostridia-like bacterium design ated BVAB1 decreased significantly with oral ( p = .002 , p = .02 ) but not vaginal therapy ( p = .141 , p = .126 ) . The fastidious bacterium BVAB3 did not significantly decrease with either treatment . Concentrations of Atopobium spp . , reportedly resistant to metronidazole in vitro , dropped significantly with oral ( p = .002 ) and vaginal ( p = .001 ) treatment . There was no significant difference in the magnitude of change in bacterial concentrations between oral and vaginal treatment arms for any of the bacterial species . Lactobacillus crispatus concentrations did not change . Conclusion Both oral and vaginal metronidazole therapy in pregnant women result in a significant decrease in concentrations of most BV-associated anaerobic bacteria , with the exception that Leptotrichia , Sneathia and BVAB1 do not significantly decrease with vaginal metronidazole therapy . These data suggest that the route of antibiotic administration has a minor impact on bacterial eradication in pregnant women with BV.Trail Registration This trial is registered with Clinical Trials.gov , number Urogenital infections afflict an estimated one billion people each year . The size of this problem and the increased prevalence of multi-drug resistant pathogens make it imperative that alternative remedies be found . A r and omized , placebo-controlled trial of 64 healthy women given daily oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 60 days showed no adverse effects . Microscopy analysis showed restoration from asymptomatic bacterial vaginosis microflora to a normal lactobacilli colonized microflora in 37 % women during lactobacilli treatment compared to 13 % on placebo ( P=0.02 ) . Lactobacilli were detected in more women in the lactobacilli-treated group than in the placebo group at 28 day ( P=0.08 ) and 60 day ( P=0.05 ) test points . Culture findings confirmed a significant increase in vaginal lactobacilli at day 28 and 60 , a significant depletion in yeast at day 28 and a significant reduction in coliforms at day 28 , 60 and 90 for lactobacilli-treated subjects versus controls . The combination of probiotic L. rhamnosus GR-1 and L. fermentum RC-14 is not only safe for daily use in healthy women , but it can reduce colonization of the vagina by potential pathogenic bacteria and yeast OBJECTIVE Bacterial vaginosis ( BV ) is associated with preterm delivery , but there is little evidence that treatment improves pregnancy outcomes . We examined whether oral or vaginal metronidazole treatment for BV in early pregnancy was more effective in restoring the normal vaginal environment . METHODS This was a r and omized controlled trial comparing oral and intravaginal metronidazole for treatment of BV in early pregnancy ( < 20 weeks ) . Vaginal sample s collected at baseline and 4 weeks after treatment were evaluated using gram stain , culture , colorimetric detection of sialidase , and immunoassay for measurement of proinflammatory cytokines interleukins-1beta , -6 , -8 ( IL-1beta , IL-6 , IL-8 ) and secretory leukocyte protease inhibitor ( SLPI ) . We compared the effect of treatment between groups ( using chi-square and t test ) and within individuals ( McNemar 's test ) . RESULTS Of 126 subjects , 108 ( 86 % ) completed follow-up ( 55 oral , 53 intravaginal ) . Of the study population , 34 % achieved therapeutic cure , and this was not different between treatment groups . BV-associated bacteria were significantly reduced in both groups , but few subjects regained colonization with protective lactobacilli . Among women who achieved therapeutic cure , the level of IL-1beta dropped significantly ( p < 0.001 ) and SLPI increased ( p = 0.003 ) . More women in the vaginal treatment group had undetectable sialidase after treatment ( p = 0.013 ) . CONCLUSIONS Treatment with oral or intravaginal metronidazole in early pregnancy reduced colonization with BV-associated bacteria but was not effective in achieving therapeutic cure or in restoring healthy vaginal lactobacilli BACKGROUND Bacterial vaginosis ( BV ) recurrence posttreatment is common . Our aim was to determine if behaviors were associated with  BV recurrence in women in a r and omized controlled trial ( RCT ) . METHODS Symptomatic 18- to 50-year-old females with BV ( ≥3 Amsel criteria and Nugent score [ NS ] = 4 - 10 ) were enrolled in a 3-arm r and omized double-blind RCT Melbourne Sexual Health Centre , Australia , in 2009 - 2010 . All 450 participants  received oral metronidazole ( 7 days ) and were equally r and omized to vaginal clindamycin , lactobacillus-vaginal probiotic or vaginal placebo . At 1 , 2 , 3 , and 6 months , participants self-collected  vaginal smears and completed question naires . Primary endpoint was NS = 7 - 10 . Cox regression was used to estimate hazard ratios ( HRs ) for risk of BV recurrence associated with baseline and longitudinal characteristics . RESULTS Four hundred four ( 90 % ) women with postr and omization data contributed to analyses  . Cumulative 6-month BV recurrence was 28 % ( 95 % confidence interval [ CI ] , 24%-33 % ) and not associated with treatment . After stratifying for treatment and adjusting for age and sex frequency , recurrence was associated with having the same pre-/posttreatment sexual partner ( adjusted HR [ AHR ] = 1.9 ; 95 % CI , 1.2 - 3.0 ) , inconsistent condom use ( AHR = 1.9 ; 95 % CI , 1.0 - 3.3 ) , and being non-Australian ( AHR = 1.5 ; 95 % CI , 1.0 - 2.1 ) , and halved with use of an estrogen-containing contraceptive ( AHR = 0.5 ; 95 % CI , .3-.8 ) . CONCLUSIONS Risk of BV recurrence was increased with the same pre-/posttreatment sexual partner and inconsistent condom use , and halved with use of estrogen-containing contraceptives . Behavioral and contraceptive practice s may modify the effectiveness of BV treatment . CLINICAL TRIALS REGISTRATION ACTRN12607000350426 The efficacy of vaginal tablets ( Gynoflor ) containing 50 mg of a lyophilisate of viable , H2O2-producing Lactobacillus acidophilus ( at least 10(7 ) colony forming units/tablet ) and 0.03 mg estriol ( CAS 50 - 27 - 1 ) for the treatment of bacterial vaginosis ( BV ) was tested in a multicentric , r and omised , placebo-controlled clinical trial with parallel-group design . 32 non-menopausal women with positive diagnoses for BV , including intermediate cases , participated in the trial . Patients were diagnosed using the classical clinical parameters of BV according to Amsel and using microscopic analysis of the Gram-stained vaginal smear . A positive clinical diagnosis of BV required at least 2 of the following 4 clinical criteria to be positive ; greyish-white , homogeneous leukorrhea ; vaginal pH > 4.5 ; KOH test for volatile amines ; presence of clue cells . Microscopic diagnosis of BV , on the other h and , was obtained if examination of the Gram-stained vaginal smear showed less than 6 lactobacilli per field of view ( 1000 x magnification ) . This corresponds to another definition of BV as " lactobacilli deficiency syndrome " . The efficacy of the 6-day therapy with 1 - 2 vaginal tablets daily was evaluated using both clinical and microscopic analysis . Using Amsel 's classical clinical parameters of BV , the cure rate ( defined as < or = 1 of the 4 clinical criteria positive ) two weeks after the start of therapy was 77 % in the verum group and 25 % in the placebo group . Four weeks after the start of therapy , the cure rate was 88 % in the verum group and 22 % in the placebo group . At both control examinations , the cure rate for the test group was significantly higher than that for the placebo group ( p < 0.05 , Fisher 's exact test , 2-sided , significance level 0.05 ) . In addition , the trial showed that after 6 days of treatment with the test preparation , the lactobacilli were capable of recolonising the vagina . A significant increase in the number of lactobacilli was observed in the Gram-stained vaginal smear for the patient group treated with the test preparation compared to the placebo patient group ( p < 0.05 , Fisher 's exact test , 2-sided , significance level 0.05 ) , two and four weeks after the start of the 6-day treatment Objective : Vaginal colonisation with Lactobacillus species is characteristic of normal vaginal ecology . The absence of vaginal lactobacilli , particularly hydrogen peroxide (H2O2)-producing isolates , has been associated with symptomatic bacterial vaginosis ( BV ) and increased risk for HIV-1 acquisition . Identification of factors associated with vaginal Lactobacillus colonisation may suggest interventions to improve vaginal health . Methods : We conducted a prospect i ve cohort study of correlates of vaginal Lactobacillus colonisation among Kenyan HIV-1 seronegative female sex workers . At monthly follow-up visits , vaginal Lactobacillus cultures were obtained . Generalised estimating equations were used to examine demographic , behavioural and medical correlates of Lactobacillus isolation , including isolation of H2O2-producing strains . Results : Lactobacillus cultures were obtained from 1020 women who completed a total of 8896 follow-up visits . Vaginal washing , typically with water alone or with soap and water , was associated with an approximately 40 % decreased likelihood of Lactobacillus isolation , including isolation of H2O2-producing strains . Recent antibiotic use , excluding metronidazole and treatments for vaginal c and idiasis , reduced Lactobacillus isolation by ∼30 % . H2O2-producing lactobacilli were significantly less common among women with Trichomonas vaginalis infection and those who were seropositive for herpes simplex virus type 2 . In contrast , H2O2-producing lactobacilli were significantly more common among women with concurrent vaginal c and idiasis . Conclusions : Modifiable biological and behavioural factors are associated with Lactobacillus colonisation in African women . Our results suggest intervention strategies to improve vaginal health in women at high risk for HIV-1 Objective : The objective of this study was to determine why different criteria for response to treatment of bacterial vaginosis ( BV ) led to markedly different conclusions about treatment efficacy in a r and omized trial comparing metronidazole gel versus metronidazole/nystatin ovules . Study : We compared the impact of two treatment regimens on individual components of Amsel and Nugent criteria at follow-up visits 14 , 42 , and 104 days after initiating treatment . Results : Compared with gel , ovules more effectively eliminated amines , clue cells , and Gardnerella , Prevotella , or Mobiluncus morphotypes from vaginal fluid , thus achieving cure based on “ usual ” criteria ( absence of BV by Amsel or Nugent criteria ) , but did not more effectively restore Lactobacillus morphotypes or lower vaginal pH , thus not meeting Federal Drug Administration ( FDA ) criteria for cure . Conclusion : Because early vaginal recolonization by lactobacilli was poor after both gel and ovules , FDA draft criteria for cure missed marked differences in treatment efficacies against Gardnerella , clue cells , and amines . Cure defined more “ usually ” may give more useful information Intermittent treatment with an acid lactate gel ( Lactal , ACO , Sweden ) reduced symptoms of  bacterial vaginosis ( BV )  and promoted the reestablishment of the normal vaginal flora of lactobacilli . Forty-two women seriously affected by recurrent BV were initially given acid gel ( lactate gel , pH 3.8 , 5 ml ) to be inserted into the vagina daily for 7 consecutive days . Thereafter they entered into a double blind clinical trial and were treated prophylactically 3 days monthly for 6 months with either lactate gel or a placebo gel . Women treated with the lactate gel were clinical ly improved , i.e. no signs of BV in 88 % compared to 10 % in the placebo group ( p less than 0.001 ) . The vaginal lactobacilli flora was reestablished in 83 % of the lactate group and in 16 % of the placebo group . Local intermittent application of lactate gel was found to be free of side effects and is a preferable alternative to repeated treatments with antibiotics in patients with recurrent BV OBJECTIVE To assess women 's satisfaction with a vaginal capsule containing human-derived , H(2)O(2)-producing Lactobacillus crispatus at completion of a r and omized , placebo-controlled study for treatment of bacterial vaginosis ( BV ) . METHODS Women aged 14 - 35 years with BV were r and omized  to Lactobacillus or placebo intravaginal capsule twice daily for 3 days monthly for 3 months . Attitudes were assessed with a st and ardized scale at the final follow-up visit , and associations of satisfaction with clinical and gram stain cure of BV were determined . RESULTS Four hundred twenty-four women were r and omized at enrollment , and 232 ( 55 % ) provided data on satisfaction at the final visit . Overall , satisfaction with the capsule was high and was independent of subjects ' race , age , and prior history of BV . Report of satisfaction with the capsule , belief that it contained healthy bacteria , and belief that its use improved vaginal health were directly related to clinical cure and to improved Nugent score . Except for women who had BV at the final follow-up visit , most subjects believed that the capsule contained healthy bacteria independent of any outcome reflecting cure . Willingness to use the capsule again was not significantly related to whether subjects experienced clinical cure or normalization of Nugent score at either visit . Adverse effects were rare and were largely related to a perceived difference in vaginal discharge . CONCLUSIONS Satisfaction with an intravaginal capsule and positive beliefs about its use for BV treatment were prevalent , especially among women with a clinical and microbiological response to BV therapy . However , most women expressed willingness to use the product again regardless of clinical response . Acceptability of and interest in alternative BV treatments , such as L. crispatus intravaginal applications , are high Background : Bacterial vaginosis ( BV ) recurs frequently after metronidazole treatment . This r and omized , single-masked clinical trial evaluated the efficacy of topical application of 62 % ethyl alcohol in emollient gel ( gel ) to the penis by male partners of women diagnosed with BV for preventing post-treatment BV recurrence . Methods : Among 587 Kenyan women presenting with vulvovaginal symptoms , 236 had BV ( vaginal Gram stain Nugent score ≥7 ) , of whom 223 ( 94.3 % ) agreed , along with their partners , to be r and omized : 115 to the intervention and 108 to the control arm . In the intervention arm , male partners agreed to apply gel each morning , and before and after sexual intercourse . All couples received counseling , condoms , and syndromic treatment of sexually transmitted infection symptoms . Follow-up visits were scheduled 1 week , 1 month , and 2 months postenrollment , with vaginal Gram stains at every visit and culture for H2O2-producing lactobacilli at the 2-month visit . The primary outcome was time to diagnosis of BV during follow-up . Results : In the primary intent-to-treat analysis , diagnosis of BV was significantly more frequent in the intervention arm ( hazard ratio : 1.44 , 95 % confidence interval : 1.01–2.04 ) . After adjustment for baseline covariates , the hazard ratio was 1.39 ( 95 % confidence interval : 0.98–1.99 ) . At the 2-month visit , prevalences of any vaginal lactobacilli or of H2O2-producing lactobacilli did not differ appreciably in the 2 study arms ( P = 0.81 and 0.32 , respectively ) . Conclusion : Daily use of the 62 % ethyl alcohol gel by men before and after sex significantly increased persistence or early recurrence of BV in their partners through 2 months after metronidazole treatment . However , no difference was observed in prevalences of vaginal lactobacilli within this same period
The results do not provide sufficient evidence for or against recommending probiotics for the treatment of BV .
BACKGROUND The dominance of lactobacilli in healthy vaginal microbiota and its depletion in bacterial vaginosis ( BV ) has given rise to the concept of oral or vaginal instillation of probiotic Lactobacillus strains for the management of this condition .
OBJECTIVES To ascertain the efficacy of probiotics in the treatment of BV .