Clinical Trial: Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Universidad Complutense de Madrid

Current Primary Outcome: Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ]

Original Secondary Outcome: Same as current

Information By: Universidad Complutense de Madrid

Dates:
Date Received: July 14, 2008
Date Started: July 2008
Date Completion:
Last Updated: May 22, 2009
Last Verified: May 2009