PMID- 20644497
OWN - NLM
STAT- MEDLINE
DCOM- 20110316
LR  - 20220331
IS  - 1537-4521 (Electronic)
IS  - 0148-5717 (Linking)
VI  - 37
IP  - 12
DP  - 2010 Dec
TI  - Phase 2a study assessing colonization efficiency, safety, and acceptability of 
      Lactobacillus crispatus CTV-05 in women with bacterial vaginosis.
PG  - 745-50
LID - 10.1097/OLQ.0b013e3181e50026 [doi]
AB  - BACKGROUND: 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. METHODS: 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 x 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. RESULTS: 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 (21%), vaginal odor (21%), and genital pruritus (17%). No 
      grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was 
      seen during colposcopic evaluation. The product was well tolerated and accepted. 
      CONCLUSIONS: LACTIN-V colonized well, and was safe and acceptable in women 
      treated for BV.
FAU - Hemmerling, Anke
AU  - Hemmerling A
AD  - Department of Obstetrics, Gynecology, and Reproductive Sciences, University of 
      California, San Francisco, CA 94105, USA. ahemmerling@globalhealth.ucsf.edu
FAU - Harrison, William
AU  - Harrison W
FAU - Schroeder, Adrienne
AU  - Schroeder A
FAU - Park, Jeanna
AU  - Park J
FAU - Korn, Abner
AU  - Korn A
FAU - Shiboski, Stephen
AU  - Shiboski S
FAU - Foster-Rosales, Anne
AU  - Foster-Rosales A
FAU - Cohen, Craig R
AU  - Cohen CR
LA  - eng
SI  - ClinicalTrials.gov/NCT00635622
GR  - UL1 RR024131-01/RR/NCRR NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Sex Transm Dis
JT  - Sexually transmitted diseases
JID - 7705941
SB  - IM
MH  - Administration, Intravaginal
MH  - Adolescent
MH  - Adult
MH  - Colony Count, Microbial
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Lactobacillus/*growth & development
MH  - Middle Aged
MH  - *Patient Acceptance of Health Care
MH  - Probiotics/*administration & dosage/*adverse effects
MH  - Secondary Prevention
MH  - Treatment Outcome
MH  - Vagina/*microbiology
MH  - Vaginosis, Bacterial/microbiology/*prevention & control
MH  - Young Adult
EDAT- 2010/07/21 06:00
MHDA- 2011/03/17 06:00
CRDT- 2010/07/21 06:00
PHST- 2010/07/21 06:00 [entrez]
PHST- 2010/07/21 06:00 [pubmed]
PHST- 2011/03/17 06:00 [medline]
AID - 10.1097/OLQ.0b013e3181e50026 [doi]
PST - ppublish
SO  - Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.