PMID- 19543144
OWN - NLM
STAT- MEDLINE
DCOM- 20091123
LR  - 20211020
IS  - 1537-4521 (Electronic)
IS  - 0148-5717 (Print)
IS  - 0148-5717 (Linking)
VI  - 36
IP  - 9
DP  - 2009 Sep
TI  - Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the 
      prevention of bacterial vaginosis.
PG  - 564-9
LID - 10.1097/OLQ.0b013e3181a74924 [doi]
AB  - 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.
FAU - Hemmerling, Anke
AU  - Hemmerling A
AD  - Department of Obstetrics, Gynecology, and Reproductive Sciences, University of 
      California-San Francisco, 50 Beale Street, 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 - Cohen, Craig R
AU  - Cohen CR
LA  - eng
GR  - UL1 RR024131/RR/NCRR NIH HHS/United States
GR  - UL1 RR024131-01/RR/NCRR NIH HHS/United States
GR  - UL1 RR 024131-01/RR/NCRR NIH HHS/United States
PT  - Clinical Trial, Phase I
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  - Adult
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - *Lactobacillus
MH  - Probiotics/*administration & dosage/*adverse effects
MH  - Treatment Outcome
MH  - Vaginosis, Bacterial/*microbiology/*prevention & control
PMC - PMC2758081
MID - NIHMS126941
EDAT- 2009/06/23 09:00
MHDA- 2009/12/16 06:00
PMCR- 2010/09/01
CRDT- 2009/06/23 09:00
PHST- 2009/06/23 09:00 [entrez]
PHST- 2009/06/23 09:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
PHST- 2010/09/01 00:00 [pmc-release]
AID - 10.1097/OLQ.0b013e3181a74924 [doi]
PST - ppublish
SO  - Sex Transm Dis. 2009 Sep;36(9):564-9. doi: 10.1097/OLQ.0b013e3181a74924.