BACKGROUND: Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications. METHODS: A phase I dose-ranging safety trial tested the safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in 3 blocks of 4 (5 x 10, 1 x 10, and 2 x 10 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow-up on days 7 and 14, and had phone interviews on days 2 and 35. RESULTS: All 12 participants took 5 doses and completed study follow-up.Overall, 45 adverse events (AEs) occurred, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the 3 treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty-one (91%) AEs were mild (grade 1) in severity. All 4 moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well-tolerated and accepted. CONCLUSION: All 3 dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers.
RCT Entities:
BACKGROUND:Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications. METHODS: A phase I dose-ranging safety trial tested the safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in 3 blocks of 4 (5 x 10, 1 x 10, and 2 x 10 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow-up on days 7 and 14, and had phone interviews on days 2 and 35. RESULTS: All 12 participants took 5 doses and completed study follow-up.Overall, 45 adverse events (AEs) occurred, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the 3 treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty-one (91%) AEs were mild (grade 1) in severity. All 4 moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well-tolerated and accepted. CONCLUSION: All 3 dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers.
Authors: H L Martin; B A Richardson; P M Nyange; L Lavreys; S L Hillier; B Chohan; K Mandaliya; J O Ndinya-Achola; J Bwayo; J Kreiss Journal: J Infect Dis Date: 1999-12 Impact factor: 5.226
Authors: Ann E Stapleton; Melissa Au-Yeung; Thomas M Hooton; David N Fredricks; Pacita L Roberts; Christopher A Czaja; Yuliya Yarova-Yarovaya; Tina Fiedler; Marsha Cox; Walter E Stamm Journal: Clin Infect Dis Date: 2011-04-14 Impact factor: 9.079
Authors: Jean M Macklaim; Craig R Cohen; Gilbert Donders; Gregory B Gloor; Janet E Hill; Groesbeck P Parham; Jacques Ravel; Gregory Spear; Janneke van de Wijgert; Gregor Reid Journal: Reprod Sci Date: 2012-05-21 Impact factor: 3.060
Authors: Scott Sherrill-Mix; Kaleigh Connors; Grace M Aldrovandi; Jason M Brenchley; Charles Boucher; Frederic D Bushman; Ronald G Collman; Satya Dandekar; Nichole R Klatt; Laurel A Lagenaur; Roger Paredes; Gilda Tachedjian; Jim A Turpin; Alan L Landay; Mimi Ghosh Journal: AIDS Res Hum Retroviruses Date: 2020-09-07 Impact factor: 2.205
Authors: Craig R Cohen; Michael R Wierzbicki; Audrey L French; Sheldon Morris; Sara Newmann; Hilary Reno; Lauri Green; Steve Miller; Jonathan Powell; Thomas Parks; Anke Hemmerling Journal: N Engl J Med Date: 2020-05-14 Impact factor: 91.245
Authors: Benjamin M Ngugi; Anke Hemmerling; Elizabeth A Bukusi; Gideon Kikuvi; Joseph Gikunju; Stephen Shiboski; David N Fredricks; Craig R Cohen Journal: Sex Transm Dis Date: 2011-11 Impact factor: 2.830
Authors: Scott Sherrill-Mix; Michelle Yang; Grace M Aldrovandi; Jason M Brenchley; Frederic D Bushman; Ronald G Collman; Satya Dandekar; Nichole R Klatt; Laurel A Lagenaur; Alan L Landay; Roger Paredes; Gilda Tachedjian; Jim A Turpin; Sergio Serrano-Villar; Catherine A Lozupone; Mimi Ghosh Journal: AIDS Res Hum Retroviruses Date: 2022-01-25 Impact factor: 2.205
Authors: Anke Hemmerling; William G Harrison; Joelle Morgan Brown; Barbara Moscicki; Maria Oziemkowska; Elizabeth A Bukusi; Craig R Cohen Journal: Sex Transm Dis Date: 2012-09 Impact factor: 2.830
Authors: Brett Williams; Mimi Ghosh; Charles A B Boucher; Frederic Bushman; Stacy Carrington-Lawrence; Ronald G Collman; Satya Dandekar; Que Dang; Angela Malaspina; Roger Paredes; Cara C Wilson; Piotr Nowak; Nichole R Klatt; Laurel Lagenaur; Alan L Landay Journal: AIDS Res Hum Retroviruses Date: 2017-10-26 Impact factor: 2.205