Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Complutense de Madrid
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; beta-Lactams; Clavulanic Acid; Clavulanic Acids; Cloxacillin; Lactams

Criteria

Inclusion Criteria:

• Clinical diagnosis of mastitis

• Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk

• Milk leukocyte count higher 6 log10/mL

• Must be able to provide a milk sample without the aid of a milk pump

Exclusion Criteria:

• Mammary abscesses

• Any kind of parallel disease