NCT01505361

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: Female
• Age: 25 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mastitis

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus salivarius PS2	9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
BIOLOGICAL	Excipient (milk powder)	100 mg/once a day from 30 week of pregnancy until birth

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2012-01-06
• Last updated: 2012-01-12

Locations

1 site across 1 country: Spain