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. Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study 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 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. 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 Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 to prevent or cure bacterial vaginosis among women with HIV. Women's satisfaction with an intravaginal Lactobacillus capsule for the treatment of bacterial vaginosis. Vaginal lactobacilli, microbial flora, and risk of human immunodeficiency virus type 1 and sexually transmitted disease acquisition. [Effectiveness of oral administration of Lactobacillus paracasei subsp. paracasei F19 in association with vaginal suppositories of Lactobacillus acidofilus in the treatment of vaginosis and in the prevention of recurrent vaginitis]. Probiotic Lactobacillus dose required to restore and maintain a normal vaginal flora. Prospective study of correlates of vaginal Lactobacillus colonisation among high-risk HIV-1 seronegative women Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. Phase 2a Study Assessing Colonization Efficiency, Safety, and Acceptability of Lactobacillus crispatus CTV-05 in Women With Bacterial Vaginosis A pilot study evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection.
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 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 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 : 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 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 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 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 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 A prospect i ve cohort study was conducted to examine the relationship between vaginal colonization with lactobacilli , bacterial vaginosis ( BV ) , and acquisition of  human immunodeficiency virus type 1 ( HIV-1 ) and sexually transmitted diseases in a population of sex workers in Mombasa , Kenya . In total , 657 HIV-1-seronegative women were enrolled and followed at monthly intervals . At baseline , only 26 % of women were colonized with Lactobacillus species . During follow-up , absence of vaginal lactobacilli on culture was associated with an increased risk of acquiring HIV-1 infection ( hazard ratio [ HR ] , 2.0 ; 95 % confidence interval [ CI ] , 1.2 - 3.5 ) and gonorrhea ( HR , 1.7 ; 95 % CI , 1.1 - 2.6 ) , after controlling for other identified risk factors in separate multivariate models . Presence of abnormal vaginal flora on Gram 's stain was associated with increased risk of both HIV-1 acquisition ( HR , 1.9 ; 95 % CI , 1.1 - 3.1 ) and Trichomonas infection ( HR , 1.8 ; 95 % CI , 1.3 - 2.4 ) . Treatment of BV and promotion of vaginal colonization with lactobacilli should be evaluated as potential interventions to reduce a woman 's risk of acquiring HIV-1 , gonorrhea , and trichomoniasis AIM The aim of this paper was to estimate the effectiveness of the contemporary oral administration of Lactobacilllus paracasei subsp paracasei F19 in association with vaginal suppositories containing Lactobacilllus acidofilus in the treatment of bacterial vaginosis and in the prevention of recurrent vaginitis . METHODS We have recruited 60 women in good health , aged between 18 and 40 years with suspect or confirmed diagnosis of bacterial vaginosis . The women were r and omized in 2 groups : Group A treated with vaginal suppositories containing Lactobacillus acidofilus ( Calagin , SIFFRA , Florence ) ; Group B treated with the same vaginal suppositories + probiotic containing Lactobacilllus paracasei subsp paracasei F 19 for oral administration ( Gene-filus F19 , SIFFRA , Florence ) . The patients were examined at the end of therapy ( 3 months ) and then after 3 months from the end of treatment . RESULTS In both groups at end of therapy there was a significant reduction of vaginal pH , an improvement of sniff test and of the subjective symptomatology after 3 months of treatment which still decreased during follow-up ( 3 months ) . In Group B there was a meaningful reduction of vaginal pH and of sniff test at the end of therapy and a maintenance of positive effect also after 3 months . CONCLUSIONS The results obtained in this study show that the therapy with vaginal Lactobacillus in the treatment of bacterial vaginosis is successful . The association of oral administration is useful to balance the vaginal environment with the intestinal microflora with improvement of long-term results . The use of probiotics was determinant in the treatment of a pathology like bacterial vaginosis and as an alternative to the conventional local antibiotic therapies 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 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 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 ) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment . Methods : A phase 2a study assessed colonization efficiency , safety , tolerability , and acceptability of Lactobacillus crispatus CTV-05 ( LACTIN-V ) administered by a vaginal applicator . Twenty-four women with BV were r and omized in a 3:1 ratio of active product to placebo . Participants used LACTIN-V at 2 × 109 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days , followed by a weekly application over 2 weeks . They returned for follow-up on Days 10 and 28 . Results : Sixty-one percent of the 18 women r and omized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28 . Among LACTIN-V users with complete adherence to the study regimen , 78 % were colonized at Day 10 or Day 28 . Of the 120 adverse events ( AEs ) that occurred , 108 ( 90 % ) and 12 ( 10 % ) were of mild and moderate severity , respectively . AEs were evenly distributed between the LACTIN-V and placebo group . Of the total AEs , 93 ( 78 % ) were genitourinary in origin . The most common genitourinary AEs included vaginal discharge ( 46 % ) , abdominal pain ( 46 % ) , dysuria ( 21 % ) , pollakiuria ( 21 % ) , vaginal odor ( 21 % ) , and genital pruritus ( 17 % ) . No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation . The product was well tolerated and accepted . Conclusions : LACTIN-V colonized well , and was safe and acceptable in women treated for BV Changes in the indigenous vaginal microflora with uropathogenic bacteria can predispose women to frequently recurring bacterial cystitis . Lactobacilli used as probiotics have played an important role in preventing the colonization of pathogenic bacteria in the vagina . A prospect i ve clinical pilot study was performed to confirm the safety and effectiveness of Lactobacillus vaginal suppositories against the recurrence of bacterial urinary tract infection ( UTI ) . The patients enrolled in the study were instructed to administer vaginal suppositories containing the strain Lactobacillus crispatus GAI 98322 . A significant reduction in the number of recurrences was noted , without any adverse complication ( P=0.0007 ) . The administration of vaginal suppositories containing L. crispatus GAI 98332 seemed to be a safe and promising treatment for the prevention of recurrent UTI
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 .