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Lcr6.0
L. crispatus CTV-05 Research
Mostly mechanism / observational
16 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most L. crispatus CTV-05 studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality randomised trials published 2009–2026 with a typical study size of 66 participants.
Based on 16 studies · 8 RCTs · 1,549 total participants
Confidence
High confidence
By outcome
Bacterial vaginosis
Mostly mechanism / observational8 studies
Vaginal colonisation & microbiome
Mostly mechanism / observational6 studies
Safety & local tolerance
Mostly mechanism / observational6 studies
Urinary tract infection
Too few graded studies2 studies
Genital inflammation & immunology
Too few graded studies2 studies
Pregnancy & preterm birth
Too few graded studies2 studies
Active research area
9 studies in the last 5 years
200920172026
1RCTn=228 · medium study2020
In plain English: The anchor trial: vaginal L. crispatus CTV-05 given after metronidazole cut bacterial-vaginosis recurrence from 45% to 30%.
Cohen CR et al. · N Engl J Med (2020)
Recurrence of bacterial vaginosis by week 12: 30% (46/152) with Lactin-V vs 45% (34/76) with placebo; risk ratio 0.66 (95% CI 0.44-0.87), P=0.01
Risk ratio for recurrence by week 24: 0.73 (95% CI 0.54-0.92)
L. crispatus CTV-05 was detected in 79% of the Lactin-V group at the 12-week visit
In plain English: Well-designed longitudinal and site-specific trials are required to clarify the effectiveness of microbiota-targeted interventions in IVF/ICSI.
Ma G, Zeng R, Cai R, He B, Han J, Gao R, Qin L. · BMC pregnancy and childbirth (2026)
Longer-term or individualized probiotic regimens appeared to increase Lactobacillus abundance and were associated with improved reproductive outcomes, whereas short-term interventions demonstrated minimal benefit.
Conclusion Species-level and site-specific reproductive tract microbiota profiles appear to better predict assisted reproductive technology outcomes than diversity measures alone.
Personalized or longer-duration probiotic strategies may hold therapeutic potential; however, current evidence remains limited and heterogeneous.
In plain English: Intravaginal administration appears to offer the greatest clinical benefit and could be a valuable non-antibiotic alternative for reducing the pressure for antimicrobial resistance.
Yauri-Idelfonso M, Picón-Rafaelo C, Rosales-Goñe P, Pulido-Capurro V, Acevedo-Flores J, Gómez-Gonzales W, Arteaga-Livias K. · Journal of global antimicrobial resistance (2026)
The most precise effect estimate available was a relative risk of 0.50 (95% CI: 0.20-1.20) for intravaginal Lactobacillus crispatus, with a recurrence rate of 15% versus 27% in the placebo group.
Intravaginal administration showed a consistent trend toward greater clinical benefit across all studies, associated with effective vaginal recolonisation.
In plain English: Oral intake of L. crispatus LMG S-29995, L. brevis, and L. acidophilus can significantly decrease percent of recurrences of BV in recently treated women and prolong time to recurrence of the disease.
Reznichenko H et al. · Journal of lower genital tract disease (2020)
Recurrence of BV was documented in 15 (18.3%) of 82 women in the verum group and 27 (32.1%) of 84 in the placebo group (p = .014).
Oral intake of L. crispatus LMG S-29995, L. brevis, and L. acidophilus can significantly decrease percent of recurrences of BV in recently treated women and prolong time to recurrence of the disease.
In plain English: Conclusions This randomised trial will investigate ability of an oral probiotic containing L. crispatus to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.
A total of 126 women are required to detect a 25 % increase in detectable L. crispatus.
Results The primary outcome is detectable L. crispatus in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing.
Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.
In plain English: Despite the limitations of our study, it is the first demonstration that it is possible to intervene orally with an L. crispatus probiotic to bring about a change in CST status and, in parallel, increased HPV clearance.
DI Pierro F et al. · Minerva obstetrics and gynecology (2021)
After 90 days of oral treatment with a probiotic (L. crispatus M247) we observed a reduction of approximately 70% in HPV positivity and a significant change in CST status with 94% of women now classified as CST I.
Despite the limitations of our study, it is the first demonstration that it is possible to intervene orally with an L. crispatus probiotic to bring about a change in CST status and, in parallel, increased HPV clearance.
In plain English: The recurrent-UTI trial did NOT reach statistical significance — the confidence interval includes no effect.
Stapleton AE et al. · Clin Infect Dis (2011)
Recurrent UTI in 7/48 (15%) receiving Lactin-V vs 13/48 (27%) on placebo; relative risk 0.5 (95% CI 0.2-1.2) — NOT statistically significant
High-level vaginal colonisation throughout follow-up was associated with reduced recurrence only in the Lactin-V arm (RR 0.07 vs 1.1 for placebo, P<0.01) — a within-arm association, not a randomised comparison
100 premenopausal women with recurrent UTI, treated first with antimicrobials for acute UTI
In plain English: Lower genital inflammation markers persisting 13 weeks after dosing stopped — but measured only in a selected, highly adherent subset.
Armstrong E et al. · Lancet Microbe (2022)
Vaginal IL-1α was significantly lower with LACTIN-V (β 0.310, SE 0.149; p=0.042)
Soluble E-cadherin, a biomarker of epithelial barrier disruption, was also lower (0.429, SE 0.199; p=0.035)
Primary outcomes were measured at 24 weeks — 13 weeks after treatment ended
In plain English: An uncontrolled observational study in pregnancy: tolerable and acceptable, but with no control group it cannot demonstrate any benefit.
Bayar E et al. · Benef Microbes (2023)
OBSERVATIONAL, single-arm study — there was no randomised control group
61 women in the final cohort (73 recruited, 8 withdrew); course started at 14 weeks gestation, 5 consecutive days then weekly for 6 weeks
Self-reported compliance was 93%; 97% of those completing the questionnaire would use it again