At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period
In Brief
A Phase 3 clinical trial evaluating Lactobacillus salivarius HN6, Lactobacillus reuteri CR20, and 2 other interventions for Mastitis. Completed, enrolled 300 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
9 log colony-forming units, capsules, daily, four weeks
9 log colony-forming units, capsules, daily, four weeks
9 log colony-forming units, capsules, daily, four weeks
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)