NCT00716183

Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: Female
• Age: 19 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.

Conditions

• Mastitis

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus salivarius HN6	9 log colony-forming units, capsules, daily, four weeks
BIOLOGICAL	Lactobacillus reuteri CR20	9 log colony-forming units, capsules, daily, four weeks
BIOLOGICAL	Lactobacillus fermentum LC40	9 log colony-forming units, capsules, daily, four weeks
DRUG	Beta-lactam antibiotic	Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis)

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-07-01
• Completion: 2009-05-01
• First posted: 2008-07-16
• Last updated: 2009-05-25

Locations

1 site across 1 country: Spain