2020年5月13日 · Lactin-V is designed to promote a community state type (i.e., microbial composition) with a predominance of L. crispatus 11 after treatment with vaginal 0.75% metronidazole gel.

LACTIN-V, also known as CTV-05 or as Lactobacillus crispatus CTV-05, is a live biopharmaceutical medication containing a strain of Lactobacillus crispatus (L. crispatus) which is under development for the treatment of urinary tract infections (UTIs) and bacterial vaginosis (BV). [1] [2] It is administered intravaginally and is described as the first vaginal microbiome (VMB) …

Osel’s LACTIN-V is a live biotherapeutic product addressing women’s health disorders. It incorporates a single species and strain of Lactobacillus that is part of the natural microbiome of healthy women and that has been selected for features that restore health and prevent recurrence of infection.In particular, LACTIN-V fosters the conditions observed in healthy women that …

LACTIN-V. Osel’s LACTIN-V is a live biotherapeutic product addressing women’s health disorders. LACTIN-V is under development for preventing recurrent BV and preterm birth. It contains Lactobacillus crispatus CTV-05, a single strain of hydrogen peroxide-producing vaginal Lactobacillus that is part of the natural vaginal microbiome of many healthy women.

Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa ...

2022年4月21日 · Treatment with LACTIN-V following standard antibiotics has been shown to reduce bacterial vaginosis recurrence compared with placebo, even at 3 months after the last dose. 20 In this study, we show that LACTIN-V treatment was also associated with sustained reductions in biomarkers of genital inflammation and epithelial barrier damage, through ...

2020年6月2日 · The scientists hypothesized that LACTIN-V treatment could prevent the growth of more harmful bacteria that cause BV. Vaginal smear specimen with two epithelial cells. While the lower one is normal, the top cell is covered by bacteria, which gives the cell a roughened, stippled appearance—a sign that a person may have bacterial vaginosis. ...

2020年5月14日 · 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 ...

2023年3月14日 · The vaginal microbiota is a determinant for the risk of preterm birth (PTB). Dominance of the vaginal niche by Lactobacillus crispatus associates with term delivery. This is the first observational clinical study of live vaginal biotherapeutics (Lactobacillus crispatus CTV-05 (LACTIN-V)) in pregnant women at high-risk of PTB.The primary aim was to explore safety, …

Lactin-V to Prevent Recurrence of Bacterial Vaginosis B acterial vaginosis affects 15 to 50% of women of reproductive age worldwide. 1 After treatment with an antibiotic agent,

LACTIN-V administration was associated with the concentrations of soluble immune factors and abundances of multiple bacterial taxa. To explore potential causal pathways underpinning these relationships, we assessed the mediating effects of key bacterial taxa on the relationship between LACTIN-V treatment and concentrations of IL-1α, soluble E ...

2020年5月13日 · LACTIN-V, which is produced by Osel, Inc. of Mountain View, Calif., comes in a powder form that women self-administer with a vaginal applicator. Once the healthy bacteria in the powder colonize the vagina, they produce lactic acid, which inhibits the growth of bacteria associated with BV. LACTIN-V is stable for more than a year at room ...

Previous formulations of LACTIN-V at lower concentrations administered in a gelatin capsule appeared to be safe in clinical trials when tested for prevention of BV and recurrent urinary tract infection. 21 However, the gelatin capsules dissolved slowly in the vagina, probably impeding vaginal colonization by L. crispatus CTV-05 which reached 40 ...

2025年3月5日 · Cohen CR, Wierzbicki MR, French AL, et al. Randomized trial of Lactin-V to prevent recurrence of bacterial vaginosis. N Engl J Med 2020;382:1906-1915. Crossref. PubMed. Web of Science.

LACTIN-V is stable for more than a year at room temperature, and more than two years in the refrigerator. The 228 women in the trial used LACTIN-V once a day for five days, and then twice a week for 10 weeks. Researchers said the product’s ease of use could make it an ideal medication for women around the world.

2020年8月19日 · To the Editor: In their trial of Lactobacillus crispatus CTV-05 (Lactin-V), Cohen et al. (May 14 issue) offer hope for the prevention of bacterial vaginosis.1 The protective effect of the treatment...

The effect of LACTIN-V on BV recurrence compared to placebo differed by initial clinical BV cure status (p=0.02 by 12 weeks, and p=0.08 by 24 weeks). The LACTIN-V effect was only present after clinical BV cure. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (CI: 0.35, 0.77) among participants with initial clinical BV ...

2024年6月1日 · The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had ...

Lactin-V is designed to promote a community state type (i.e., microbial composition) with a predominance of L. crispatus 11 after treatment with vaginal 0.75% metronidazole gel. In previous clinical trials, no serious or grade 3 adverse events that were considered to be related to the use of Lactin-V were reported. 13 ...

from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=228). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (β coefficient 0·310, SE 0·149; p=0·042) and soluble