Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

Summary

The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.

Timeline

Start

2006-01

Primary completion

2009-01

Completion

2009-08

Outcome

Missed primary endpoint

Stopped (Business): “Limitation of funding”

paper they were non-significant (ns) with p = 0.31 and 0.14. PMID 22059409 ↗

Publications

• Background Andrews WW. Cervicovaginal cytokines, vaginal infection, and preterm birth. Am J Obstet Gynecol. 2004 May;190(5):1179. doi: 10.1016/j.ajog.2004.04.016. No abstract available.
• Krauss-Silva L, Moreira ME, Alves MB, Braga A, Camacho KG, Batista MR, Almada-Horta A, Rebello MR, Guerra F. A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results. Trials. 2011 Nov 8;12:239. doi: 10.1186/1745-6215-12-239.
• Krauss-Silva L, Moreira ME, Alves MB, Rezende MR, Braga A, Camacho KG, Batista MR, Savastano C, Almada-Horta A, Guerra F. Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol. Reprod Health. 2010 Jun 30;7:14. doi: 10.1186/1742-4755-7-14.

Drugs

Indications