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

Sexually Transmitted Diseases
Anke HemmerlingCraig R Cohen

Abstract

Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment. A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28. Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (...Continue Reading

References

Apr 1, 1988·American Journal of Obstetrics and Gynecology·D A EschenbachK K Holmes
Jan 1, 1983·British Journal of Hospital Medicine·S G Dawson, J R Harris
Aug 1, 1996·American Journal of Obstetrics and Gynecology·S L HillierK K Holmes
May 1, 1996·American Journal of Obstetrics and Gynecology·R L GoldenbergW W Andrews
Jun 15, 2000·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·D A EschenbachW E Stamm
Jul 27, 2004·Sexually Transmitted Diseases·Andrea WallaceDavid M Phillips
Sep 20, 2005·The Journal of Infectious Diseases·Landon MyerLouise Kuhn
Jan 2, 2007·Obstetrics and Gynecology·Jenifer E Allsworth, Jeffrey F Peipert
Jan 30, 2008·BMC Oral Health·Teija NiiranenTapani Niskanen
Feb 22, 2008·Infectious Diseases in Obstetrics and Gynecology·Christopher A CzajaWalter E Stamm
May 21, 2008·Sexually Transmitted Diseases·Michael BoltonCraig R Cohen
Jan 1, 2008·Interdisciplinary Perspectives on Infectious Diseases·Sarah CribbyGregor Reid
Jun 27, 2009·Sexually Transmitted Diseases·Michele N AustinSharon L Hillier

❮ Previous
Next ❯

Citations

Apr 19, 2011·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ann E StapletonWalter E Stamm
Jan 10, 2013·BMC Microbiology·Hidemi S YamamotoRaina N Fichorova
Oct 7, 2011·International Journal of Women's Health·Jean-Pierre Menard
Sep 27, 2014·International Journal of Oral Science·Claudia VuottoGianfranco Donelli
Jun 23, 2012·Trends in Molecular Medicine·Adrienne W PatonJames C Paton
Oct 23, 2014·BJOG : an International Journal of Obstetrics and Gynaecology·Q Abdool KarimS Abdool Karim
Apr 11, 2015·Advanced Drug Delivery Reviews·María Elena Fátima Nader-Macías, María Silvina Juárez Tomás
Jul 30, 2015·BMC Infectious Diseases·Catriona S Bradshaw, Rebecca M Brotman
Apr 11, 2015·Frontiers in Physiology·Mariya I PetrovaSarah Lebeer
May 25, 2016·Journal of Midwifery & Women's Health·Lisa HansonNasia Safdar
Jan 13, 2016·Journal of Applied Microbiology·F H Al-Ghazzewi, R F Tester
Mar 3, 2012·Reproductive Sciences·Jingru LiGregor Reid
Feb 20, 2014·Food & Function·Yi-Heng ChiuMeei-Yn Lin
Sep 2, 2019·Current Infectious Disease Reports·Jennifer E BalkusR Scott McClelland
May 14, 2020·The New England Journal of Medicine·Craig R CohenAnke Hemmerling
Feb 20, 2020·Nature Reviews. Urology·Paweł ŁaniewskiMelissa M Herbst-Kralovetz
May 8, 2020·High-throughput·Rossella TomaiuoloValeria D'Argenio
Oct 24, 2017·Current Opinion in HIV and AIDS·Salim S Abdool KarimCheryl Baxter
Jan 19, 2019·Reproductive Medicine and Biology·Inmaculada Moreno, Carlos Simon
May 7, 2019·Frontiers in Cellular and Infection Microbiology·Empar ChenollDaniel Ramón
Sep 14, 2017·AIDS Research and Human Retroviruses·Brett WilliamsAlan L Landay
Oct 17, 2019·International Journal of Environmental Research and Public Health·Ziyue WangYingjie Zheng
May 31, 2019·Journal of the International AIDS Society·Salim S Abdool KarimBrent L Williams
Aug 12, 2020·AIDS Research and Human Retroviruses·Scott Sherrill-MixMimi Ghosh
Aug 2, 2018·Bioengineering & Translational Medicine·Ava M Vargason, Aaron C Anselmo
Mar 3, 2017·Applied Microbiology and Biotechnology·Yaxin ZhangMingdong Huang
Oct 8, 2020·Archives of Gynecology and Obstetrics·Fiona Damaris TidburyPetra Stute
Nov 14, 2020·Journal of Reproductive Immunology·Amin AbbasiLeili Aghebati-Maleki

❮ Previous
Next ❯

Related Concepts

Related Feeds

Bacterial Vaginosis

Bacterial vaginosis can increase the risk of sexually transmitted infections and in rare cases lead to pelvic inflammatory diseases. Discover the latest research on Bacterial Vaginosis here.