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Lcr6.0

L. crispatus CTV-05 – Forschung

Überwiegend Mechanismus / Beobachtung

12 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

Die meisten Studien zu L. crispatus CTV-05 sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.

Die meiste Evidenz stammt aus mittelwertigen randomisierten Studien, veröffentlicht 2009–2025 mit einer typischen Studiengröße von 61 Teilnehmenden.

Basierend auf 12 Studien · 8 RCTs · 767 Teilnehmende insgesamt

Konfidenz

Mittlere Konfidenz

Nach Outcome

Bacterial vaginosis
Überwiegend Mechanismus / Beobachtung8 Studien
Vaginal colonisation & microbiome
Überwiegend Mechanismus / Beobachtung5 Studien
Safety & local tolerance
Überwiegend Mechanismus / Beobachtung5 Studien
Genital inflammation & immunology
Zu wenige bewertete Studien2 Studien
Urinary tract infection
Zu wenige bewertete Studien1 Studie
Pregnancy & preterm birth
Zu wenige bewertete Studien1 Studie

Aktives Forschungsgebiet

5 Studien in den letzten 5 Jahren

200920172025

1RCTn=228 · medium study2020

Einfach gesagt: 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

Quelle ansehen

2RCTn=45 · small study2025

Einfach gesagt: 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

Quelle ansehen

3RCTn=82 · small study2020

Einfach gesagt: 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

Quelle ansehen

4n=35 · small study2021

Einfach gesagt: 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

Quelle ansehen

5Beobachtungsstudie2024

Einfach gesagt: 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

Quelle ansehen

6RCTn=100 · medium study2011

Einfach gesagt: 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

Quelle ansehen

7RCTn=66 · small study2022

Einfach gesagt: 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

Quelle ansehen

8RCTn=90 · small study2009

Einfach gesagt: 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

Quelle ansehen

9RCTn=24 · very small study2010

Einfach gesagt: 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%)

Quelle ansehen

10Kohorten=24 · very small study2011

Einfach gesagt: 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)

Quelle ansehen

11RCTn=12 · very small study2009

Einfach gesagt: 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%)

Quelle ansehen

12Beobachtungsstudien=61 · small study2023

Einfach gesagt: 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

Quelle ansehen

In der Forschungsbibliothek ansehen

L. crispatus CTV-05 – Forschung

Überwiegend Mechanismus / Beobachtung

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.