Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome

Summary

In the currently presented trial, investigators aim to evaluate the treatment of the intermediate vaginal microbiota during the first trimester of pregnancy with vaginal lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD. All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days) gestational weeks in study group will be treated with vaginal Lactobacilli Capsules containing L. Casei rhamnosus LCR 35

Timeline

Start

2017-05-02

Primary completion

2020-11-01

Completion

2020-12-30

Publications

• Background Petricevic L, Witt A. The role of Lactobacillus casei rhamnosus Lcr35 in restoring the normal vaginal flora after antibiotic treatment of bacterial vaginosis. BJOG. 2008 Oct;115(11):1369-74. doi: 10.1111/j.1471-0528.2008.01882.x.
• Background Kiss H, Petricevic L, Husslein P. Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery. BMJ. 2004 Aug 14;329(7462):371. doi: 10.1136/bmj.38169.519653.EB. Epub 2004 Aug 4.
• Results Farr A, Kiss H, Hagmann M, Machal S, Holzer I, Kueronya V, Husslein PW, Petricevic L. Role of Lactobacillus Species in the Intermediate Vaginal Flora in Early Pregnancy: A Retrospective Cohort Study. PLoS One. 2015 Dec 11;10(12):e0144181. doi: 10.1371/journal.pone.0144181. eCollection 2015.
• Results Petricevic L, Domig KJ, Nierscher FJ, Sandhofer MJ, Fidesser M, Krondorfer I, Husslein P, Kneifel W, Kiss H. Characterisation of the vaginal Lactobacillus microbiota associated with preterm delivery. Sci Rep. 2014 May 30;4:5136. doi: 10.1038/srep05136.

Drugs

Indications