Phase 2a Study Assessing Colonization Efficiency, Safety, and Acceptability of Lactobacillus crispatus CTV-05 in Women With Bacterial Vaginosis

Hemmerling, Anke; Harrison, W. G.; Schroeder, Adrienne; Park, Jeanna; Korn, Abner P.; Shiboski, Stephen; Foster-Rosales, Anne; Cohen, Craig R.

doi:10.1097/olq.0b013e3181e50026

Cited by 102 publications

(100 citation statements)

References 23 publications

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“…25 The study which was conducted at San Francisco General Hospital (SFGH) recruited 24 pre-menopausal women with BV from clinics in the San Francisco Bay Area and randomized them 3:1 to receive either LACTIV-V or placebo. L. crispatus CTV-05 culture and 9-bacterium specific 16S rRNA gene quantitative PCR assays were then done on vaginal swabs collected on several study visits from the 18 women receiving LACTIN-V.…”

Section: Methodsmentioning

confidence: 99%

“…22;23 A higher concentration of L. crispatus CTV-05 (2 × 10 9 cfu/dose) administered as a powder using a prefilled tampon-like applicator in healthy women as well as women with BV was also found to be safe and acceptable. 24;25 In a phase 2A trial, 61% of women were successfully colonized with L. crispatus CTV-05 at either day 10 or day 28 and 44% colonized at day 28. 25 Factors causing a sub-optimal vaginal colonization with exogenous lactobacilli are unknown, but could include high levels of BV-associated bacteria.…”

Section: Introductionmentioning

confidence: 99%

“…24;25 In a phase 2A trial, 61% of women were successfully colonized with L. crispatus CTV-05 at either day 10 or day 28 and 44% colonized at day 28. 25 Factors causing a sub-optimal vaginal colonization with exogenous lactobacilli are unknown, but could include high levels of BV-associated bacteria. This study explored the ability of L. crispatus CTV-05 to colonize the vagina in premenopausal women treated for BV and sought to determine the impact of BV-associated bacteria and other lactobacilli on CTV-05 colonization.…”

Section: Introductionmentioning

confidence: 99%

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Effects of Bacterial Vaginosis-Associated Bacteria and Sexual Intercourse on Vaginal Colonization With the Probiotic Lactobacillus crispatus CTV-05

Ngugi¹,

Hemmerling²,

Bukusi³

et al. 2011

Sexually Transmitted Diseases

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Objective-Several fastidious bacteria have been associated with bacterial vaginosis (BV), but their role in lactobacilli recolonization failure is unknown. We studied the effect of seven BVassociated bacterial species and two Lactobacillus species on vaginal colonization with L. crispatus CTV-05 (LACTIN-V).Methods-Twenty four women with BV were given a 5-day course of metronidazole vaginal gel and then randomized 3:1 to receive either LACTIN-V or placebo applied vaginally once daily for 5 initial consecutive days, followed by a weekly application over 2 weeks. Vaginal swabs for L. crispatus CTV-05 culture and 9-bacterium specific 16S rRNA gene quantitative PCR assays were analyzed on several study visits for the 18 women receiving LACTIN-V.Results-Vaginal colonization with CTV-05 was achieved in 61% of the participants receiving LACTIN-V at either the day 10 or the 28 visit and 44% at day 28. Participants not colonized with CTV-05 had generally higher median concentrations of BV-associated bacteria compared to those who colonized. Between enrollment and day 28, the median concentration of Gardnerella vaginalis minimally reduced from 10 4.5 to 10 4.3 16S rRNA gene copies per swab in women who colonized with CTV-05 but increased from 10 5.7 to 10 7.3 in those who failed to colonize (p=0.19). Similarly, the median concentration of Atopobium spp. reduced from 10 2.7 16S rRNA gene copies per swab to below limit of detection in women who colonized with CTV-05 but increased from 10 2.7 to 10 6.6 in those who failed to colonize (p=0.04). The presence of endogenous L. crispatus at enrollment was found to be significantly associated with a reduced odds of colonization with CTV-05 on day 28 (p=0.003) and vaginal intercourse during the study significantly impaired successful CTV-05 colonization (p=0.018).Corresponding Author Benjamin M. Ngugi, Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202 Nairobi, Kenya, Tel: +254-20-2720794; +254-725-808838, Fax: +254-20-2720030, bm_ngugi@yahoo.com. NIH Public Access

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effects of Bacterial Vaginosis-Associated Bacteria and Sexual Intercourse on Vaginal Colonization With the Probiotic Lactobacillus crispatus CTV-05

Ngugi¹,

Hemmerling²,

Bukusi³

et al. 2011

Sexually Transmitted Diseases

Self Cite

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“…Vaginal colonization with humanderived L. crispatus strain CTV-05 has been successful [24]. Lactobacillus crispatus CTV-05 was used as a vaginal suppository for healthy women with a history of recurrent urinary tract infections (UTIs) [25,26] and for the treatment of BV [27]. It should be mentioned that healthpromoting effects of probiotics are usually strain specific.…”

Section: Introductionmentioning

confidence: 99%

Probiotic Properties of Lactobacillus crispatus 2,029: Homeostatic Interaction with Cervicovaginal Epithelial Cells and Antagonistic Activity to Genitourinary Pathogens

Abramov

Khlebnikov

Kosarev

et al. 2014

Probiotics & Antimicro. Prot.

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Lactobacillus crispatus 2029 isolated upon investigation of vaginal lactobacilli of healthy women of reproductive age was selected as a probiotic candidate. The aim of the present study was elucidation of the role of L. crispatus 2029 in resistance of the female reproductive tract to genitourinary pathogens using cervicovaginal epithelial model. Lactobacillus crispatus 2029 has surface layers (S-layers), which completely surround cells as the outermost component of their envelope. S-layers are responsible for the adhesion of lactobacilli on the surface of cervicovaginal epithelial cells. Study of interactions between L. crispatus 2029 and a type IV collagen, a major molecular component of epithelial cell extracellular matrix, showed that 125I-labeled type IV collagen binds to lactobacilli with high affinity (Kd = (8.0 ± 0.7) × 10(-10) M). Lactobacillus crispatus 2029 consistently colonized epithelial cells. There were no toxicity, epithelial damage and apoptosis after 24 h of colonization. Electronic microscope images demonstrated intimate association between L. crispatus 2029 and epithelial cells. Upon binding to epithelial cells, lactobacilli were recognized by toll-like 2/6 receptors. Lactobacillus crispatus induced NF-κB activation in epithelial cells and did not induce expression of innate immunity mediators IL-8, IL-1β, IL-1α and TNF-α. Lactobacillus crispatus 2029 inhibited IL-8 production in epithelial cells induced by MALP-2 and increased production of anti-inflammatory cytokine IL-6, maintaining the homeostasis of female reproductive tract. Lactobacillus crispatus 2029 produced H2O2 and provided wide spectrum of antagonistic activity increasing colonization resistance to urinary tract infections by bacterial vaginosis and vulvovaginal candidiasis associated agents.

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“…However, as discussed above, it could be suggested that the treatment effect was not due to clindamycin alone considering the contribution of intensive co-treatment with estrogenic patches. Another upcoming adjuvant to or maybe even stand-alone treatment of AVM, is live biotherapeutic products (LBPs) or probiotics (Ross et al, 2008; Hemmerling et al, 2010; Larsson et al, 2011). However, strain documentation and manufacturing issues call upon well-conducted RCTs with strain specific LBPs to adequately assess the treatment effect of these new drugs.…”

Section: Discussion and Review Of The Literaturementioning

confidence: 99%

Treatment of Abnormal Vaginal Microbiota before Frozen Embryo Transfer: Case-Report and Minireview to Discuss the Longitudinal Treatment Efficacy of Oral Clindamycin

et al. 2017

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Abnormal vaginal microbiota (AVM) or bacterial vaginosis (BV) might negatively impact reproductive outcomes of in vitro fertilization (IVF). However, before randomized controlled trials are initiated to investigate cause and effect, it is necessary to establish the optimal treatment for AVM. Metronidazole seems ineffective to treat the biofilm in AVM; thus, clindamycin could be suggested as a relevant antibiotic agent for future intervention based studies. In the present case report, we present the first longitudinal follow-up of the vaginal microbiota with molecular methods during and after oral clindamycin treatment. Furthermore, we review the recent literature with the aim to discuss the optimal AVM treatment in a fertility setting. The patient was 40 years old suffering from unexplained secondary infertility. Prior to the present transfer cycle, she had had two failed IVF cycles. The tentative explanation of failed treatment was age-related aneuploidy. However, the patient asked for AVM diagnosis and she was subsequently diagnosed and treated successfully. Unfortunately, the patient did not achieve pregnancy after clindamycin treatment and two subsequent frozen embryo transfer cycles. Taken together, we report an excellent AVM treatment efficacy both short-term and long-term following oral clindamycin treatment. We discuss the potential impact on the vaginal microbiota of co-treatment with estrogen patches in the stimulated frozen embryo transfer cycle. Furthermore, we discuss future aspects of AVM treatment such as the potential impact of estrogen and live biotherapeutic products to positively modulate the microbiota of the reproductive tract.

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Phase 2a Study Assessing Colonization Efficiency, Safety, and Acceptability of Lactobacillus crispatus CTV-05 in Women With Bacterial Vaginosis

Abstract: LACTIN-V colonized well, and was safe and acceptable in women treated for BV.

Cited by 102 publications

References 23 publications

Effects of Bacterial Vaginosis-Associated Bacteria and Sexual Intercourse on Vaginal Colonization With the Probiotic Lactobacillus crispatus CTV-05

Effects of Bacterial Vaginosis-Associated Bacteria and Sexual Intercourse on Vaginal Colonization With the Probiotic Lactobacillus crispatus CTV-05

Probiotic Properties of Lactobacillus crispatus 2,029: Homeostatic Interaction with Cervicovaginal Epithelial Cells and Antagonistic Activity to Genitourinary Pathogens

Treatment of Abnormal Vaginal Microbiota before Frozen Embryo Transfer: Case-Report and Minireview to Discuss the Longitudinal Treatment Efficacy of Oral Clindamycin

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