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

NCT00716183 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	Universidad Complutense de Madrid
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	300
Start date	2008-07
Completion	2009-05

Conditions

• Mastitis

Interventions

• Lactobacillus salivarius HN6
• Lactobacillus reuteri CR20
• Lactobacillus fermentum LC40
• Beta-lactam antibiotic

Primary outcomes

• Staphylococcal and/or streptococcal count in milk — 0 and 28 days

Countries

Spain