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Lcr6.0

L. crispatus CTV-05 Research

Mostly mechanism / observational

12 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 2009–2025 with a typical study size of 61 participants.

Based on 12 studies · 9 RCTs · 767 total participants

Confidence

Moderate confidence

By outcome

Bacterial vaginosis
Mostly mechanism / observational8 studies
Vaginal colonisation & microbiome
Mostly mechanism / observational5 studies
Safety & local tolerance
Mostly mechanism / observational5 studies
Genital inflammation & immunology
Too few graded studies2 studies
Urinary tract infection
Too few graded studies1 study
Pregnancy & preterm birth
Too few graded studies1 study

Active research area

5 studies in the last 5 years

200920172025

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

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2RCTn=45 · small study2025

In plain English: The strain can establish dominance in a new setting — 41% versus 0% — but the effect was transient and no clinical outcome improved.

Hemmerling A et al. · Lancet Microbe (2025)

L. crispatus-dominant vaginal microbiomes at week 4: 13/32 (41%) with LACTIN-V vs 0/13 on placebo (p=0.0088)
By week 8 dominance had fallen to 8/31 (26%) vs 1/11 (9%) on placebo (p=0.40) — the effect was transient
Activated endocervical HIV target cells rose in the placebo group but not the LACTIN-V group (p=0.016); no HIV infections were an endpoint

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3RCTn=82 · small study2020

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.
Further research warranted to confirm findings

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4n=35 · small study2021

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.
Further research warranted to confirm findings

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5Observational2024

In plain English: A post hoc analysis of the phase 2b trial showing the benefit exists only where the antibiotic had already cleared the infection.

Hemmerling A et al. · Sex Transm Dis (2024)

This is a POST HOC analysis of the already-completed phase 2b LACTIN-V trial, not a new trial
Among women with clinical BV cure after metronidazole (88% of participants): risk ratio for recurrence by 12 weeks 0.56 (95% CI 0.35-0.77)
Among women WITHOUT post-antibiotic clinical cure: risk ratio 1.34 (95% CI 0.47-2.23) — no benefit

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6RCTn=100 · medium study2011

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

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7RCTn=66 · small study2022

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

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8RCTn=90 · small study2009

In plain English: Colonisation is fragile: intercourse and a woman's own existing L. crispatus both defeat it.

Antonio MA et al. · J Infect Dis (2009)

Of 40 participants lacking L. crispatus at enrolment, 36 (90%) were colonised by CTV-05 at one or more follow-up visits
Of 47 already colonised with L. crispatus at enrolment, only 24 (51%) were positive for CTV-05 at follow-up (P<0.001)
Unprotected sex during the first week: odds ratio 75.5 (95% CI 6.9-820.6, P<0.001) against successful colonisation

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9RCTn=24 · very small study2010

In plain English: The colonisation and tolerability study: local genitourinary complaints are common but mild, and evenly split with placebo.

Hemmerling A et al. · Sex Transm Dis (2010)

61% of the 18 women randomised to LACTIN-V were colonised at day 10 or day 28; 78% among those fully adherent
Of 120 adverse events, 108 (90%) were mild and 12 (10%) moderate; adverse events were evenly distributed between LACTIN-V and placebo
78% of adverse events were genitourinary: vaginal discharge (46%), abdominal pain (46%), dysuria (21%), urinary frequency (21%), vaginal odour (21%), genital pruritus (17%)

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10RCTn=24 · very small study2011

In plain English: Where the strain took hold, Atopobium fell below detection; where it did not, the same bacteria rose.

Ngugi BM et al. · Sex Transm Dis (2011)

Colonisation with CTV-05 was achieved in 61% at day 10 or day 28 and 44% at day 28
Median Atopobium spp. concentration fell to below the limit of detection in women who colonised but rose in those who did not (P=0.04)
Gardnerella vaginalis moved in the same direction but the difference was not significant (P=0.19)

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11RCTn=12 · very small study2009

In plain English: The first-in-human dose-ranging trial: all three vaginal dose levels were safe and acceptable in 12 healthy volunteers.

Hemmerling A et al. · Sex Transm Dis (2009)

All 12 participants took all 5 doses and completed follow-up
45 adverse events occurred, of which 41 (91%) were mild; all 4 moderate events were judged unrelated to the product
Most common genitourinary events: vaginal discharge (42%), abdominal pain (33%), metrorrhagia (33%), vulvovaginitis (33%), vaginal candidiasis (25%), vaginal odour (25%)

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12Observationaln=61 · small study2023

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

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View in Research Library

L. crispatus CTV-05 Research

Mostly mechanism / observational

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

Effect of the vaginal live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) on vaginal microbiota and genital tract inflammation among women at high risk of HIV acquisition in South Africa: a phase 2, randomised, placebo-controlled trial.

Oral Intake of Lactobacilli Can Be Helpful in Symptomatic Bacterial Vaginosis: A Randomized Clinical Study

Oral administration of Lactobacillus crispatus M247 to papillomavirus-infected women: results of a preliminary, uncontrolled, open trial

Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease.

Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection.

Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.

Vaginal colonization by probiotic Lactobacillus crispatus CTV-05 is decreased by sexual activity and endogenous Lactobacilli.

Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis.

Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05.

Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis.

Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth.