Clinical Trial: Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization

Brief Summary: In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Detailed Summary:
Sponsor: Universidad Complutense de Madrid

Current Primary Outcome: Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts [ Time Frame: Weekly during the first 6 months after birth ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab [ Time Frame: At weeks 30, 35, 40 of pregnancy ]

Original Secondary Outcome: Same as current

Information By: Universidad Complutense de Madrid

Dates:
Date Received: January 4, 2012
Date Started: November 2011
Date Completion: June 2012
Last Updated: January 11, 2012
Last Verified: January 2012