Literature DB >> 12838085

Lactobacillus crispatus capsules: single-use safety study in the Macaca nemestrina model.

Dorothy L Patton1, Yvonne T Cosgrove Sweeney, May A D Antonio, Lorna K Rabe, Sharon L Hillier.   

Abstract

BACKGROUND: Lactobacillus crispatus is a part of the normal vaginal microflora of humans. GOAL: The goal of this study was to assess whether a capsule containing an H2O2-producing strain of L crispatus (CTV-05) would alter the vaginal microflora and/or epithelial tissues when applied intravaginally in the pig-tailed macaque model. STUDY
DESIGN: Ten sexually mature female Macaca nemestrina were assessed at baseline for quantitative vaginal microbiology and vaginal pH and with colposcopy. One capsule containing 108 colony forming units of desiccated L crispatus CTV-05 was inserted into the vaginal fornix of each animal. Vaginal assessments were repeated on days 1 and 2 after capsule insertion. The L crispatus CTV-05 strain was identified with use of a DNA fingerprinting method.
RESULTS: Before product use, four of 10 animals had detectable levels of H2O2-producing lactobacilli. L crispatus CTV-05 was detected in 1 of 10 animals on day 1 and in 3 of 10 animals on day 2 following insertion of the capsule. There were no tissue changes observed by colposcopy. Vaginal pH decreased in two animals colonized by CTV-05, from 7.0 at baseline to 4.5+/-0.5 on days 1 and 2 after product use.
CONCLUSIONS: A single intravaginal application of capsules containing 108 L crispatus CTV-05 resulted in vaginal colonization in three of 10 animals 2 days after use. The absence of colposcopic changes in the vagina/cervical tissues indicates that L crispatus capsules are well tolerated.

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Year:  2003        PMID: 12838085     DOI: 10.1097/00007435-200307000-00007

Source DB:  PubMed          Journal:  Sex Transm Dis        ISSN: 0148-5717            Impact factor:   2.830


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