drugset / Trial / NCT00716183

Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

NCT00716183

Phase 2/3 Completed 300 enrolled Universidad Complutense de Madrid
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-07
Primary completion
2008-07
Completion
2009-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 500 mg Oral
Comparator Amoxicillin Other / unclassified 750 mg Oral
Subject Lactobacillus fermentum LC40 Other / unclassified 9 unknown Oral
Subject Lactobacillus reuteri CR20 Other / unclassified 9 unknown Oral
Subject Lactobacillus salivarius HN6 Other / unclassified 9 unknown Oral
Comparator amoxicillin/clavulanic acid Other / unclassified 500 mg Oral
Comparator amoxicillin/clavulanic acid Other / unclassified 750 mg Oral
Comparator cloxacillin Other / unclassified 500 mg Oral
Comparator cloxacillin Other / unclassified 750 mg Oral

Indications