Intermittent Lactobacilli-containing Vaginal Probiotic or Metronidazole Use to Prevent Bacterial Vaginosis Recurrence: Safety and Preliminary Efficacy by Microscopy and Sequencing

Wijgert, Janneke van de; Verwijs, Marijn C.; Agaba, Stephen; Bronowski, Christina; Mwambarangwe, Lambert; Uwineza, Mireille; Lievens, Eva; Nivoliez, Adrien; Darby, Alistair C.

doi:10.1101/19001156

Cited by 3 publications

(3 citation statements)

References 52 publications

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“…19,30,31 In addition, some specific strains of these species, when administered orally or intravaginally, reshaped the vaginal ecosystem and protected against vaginal infections such as bacterial vaginosis and vaginal candidiasis. [32][33][34][35][36] Consistent to these findings, after feminine product use, pathogenic flora population significantly reduced in both premenopausal and postmenopausal women. In addition, Lactobacillus population increased in the premenopausal women.…”

Section: Discussionsupporting

confidence: 65%

Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

Yoshikata¹,

Yamaguchi²,

Mase³

et al. 2022

Preprint

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Objective As estrogen level decreases with aging, the vaginal mucosa gets thinner, and collagen amount decreases. In addition, the population of Lactobacillus in the vagina declines, increasing the risk of atrophic vaginitis, bacterial vaginosis, and genitourinary symptoms in the postmenopausal women. In this study, we evaluated the effects of Lactobacillus -containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women. Methods This was a pilot randomized controlled trial in 35 premenopausal and 35 postmenopausal healthy women. For 4 weeks, treatment 1 group (14 premenopausal and 16 postmenopausal women) used the Lactobacillus-containing feminine soap and cream, and treatment 2 group (15 premenopausal and 14 postmenopausal women) used Lactobacillus-containing feminine gel in addition to soap and cream. The remaining 6 premenopausal and 5 postmenopausal women served as controls without using any products. We then compared the changes in the vaginal microbiota, genitourinary symptoms, and other related biomarkers after completion of treatment. Results Vaginal pH and pathogenic flora were reduced in both treatment groups compared to control group. It was more significant in the treatment 2 group of postmenopausal women. Genitourinary symptoms significantly improved in 60% of premenopausal women in treatment 1 group and 81.3% of postmenopausal women in treatment 2 group, compared to control group (0%). Overactive bladder symptom scores were significantly improved after using the products in the postmenopausal women suspected of having overactive bladder. Conclusion The use of Lactobacillus-containing feminine products was associated with improved vaginal ecosystem and urogenital health compared to control group, especially in those women using feminine gel.

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Section: Discussionsupporting

confidence: 65%

Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

Yoshikata¹,

Yamaguchi²,

Mase³

et al. 2022

Preprint

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“…27 Although combination metronidazole-probiotic regimens have been tested previously and some have been shown to reduce the risk of recurrence of bacterial vaginosis, the trials have generally been small and have lacked the use of standardized methods, including objective outcome measures for bacterial vaginosis recurrence and colonization by the active trial medication. [28][29][30] We found no material differences between the treatment groups in the percentage of participants who had a treatment-related adverse event or in the number, type, or severity of solicited local adverse events during the course of the 24 weeks of follow-up. These results extend earlier findings seen with Lactin-V and support the general safety of the current formulation and dosing strategy.…”

Section: Discussionmentioning

confidence: 98%

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Cohen¹,

et al. 2020

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BACKGROUND-Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS-We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS-A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group.

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Section: Discussionmentioning

confidence: 63%

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Finucane

2020

N Engl J Med

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BACKGROUND-Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.METHODS-We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.RESULTS-A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to

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Intermittent Lactobacilli-containing Vaginal Probiotic or Metronidazole Use to Prevent Bacterial Vaginosis Recurrence: Safety and Preliminary Efficacy by Microscopy and Sequencing

Cited by 3 publications

References 52 publications

Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

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