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Sponsored by: |
Universidad Complutense de Madrid |
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Information provided by: | Universidad Complutense de Madrid |
ClinicalTrials.gov Identifier: | NCT00716183 |
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.
Condition | Intervention | Phase |
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Mastitis |
Biological: Lactobacillus salivarius HN6 Biological: Lactobacillus reuteri CR20 Biological: Lactobacillus fermentum LC40 Drug: Beta-lactam antibiotic |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period |
Enrollment: | 300 |
Study Start Date: | July 2008 |
Study Completion Date: | May 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Probiotic 1: Experimental
Women receiving Lactobacillus salivarius HN6
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Biological: Lactobacillus salivarius HN6
9 log colony-forming units, capsules, daily, four weeks
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Probiotic 2: Experimental
Women receiving Lactobacillus reuteri CR20
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Biological: Lactobacillus reuteri CR20
9 log colony-forming units, capsules, daily, four weeks
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Probiotic 3: Experimental
Women receiving Lactobacillus fermentum LC40
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Biological: Lactobacillus fermentum LC40
9 log colony-forming units, capsules, daily, four weeks
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beta-lactam: Active Comparator
The evolution of the women ascribed to the other three arms will be compared with that of 100 women suffering lactational mastitis that will follow a conventional antibiotic treatment as prescribed by the pediatrician/gynecologist
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Drug: Beta-lactam antibiotic
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)
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Ages Eligible for Study: | 19 Years to 38 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Universidad Complutense de Madrid ( Juan M. Rodríguez ) |
Study ID Numbers: | Promast08 |
Study First Received: | July 14, 2008 |
Last Updated: | May 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00716183 History of Changes |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
mastitis Staphylococcus Streptococcus lactation breastfeeding |
Lactams Anti-Infective Agents Amoxicillin Pregnancy Complications Skin Diseases Clavulanic Acids Mastitis |
Anti-Bacterial Agents Cloxacillin Puerperal Disorders Clavulanic Acid Beta-Lactams Acidophilus Breast Diseases |
Anti-Infective Agents Amoxicillin Pregnancy Complications Molecular Mechanisms of Pharmacological Action Skin Diseases Clavulanic Acids Enzyme Inhibitors Mastitis |
Pharmacologic Actions Anti-Bacterial Agents Puerperal Disorders Clavulanic Acid Therapeutic Uses Beta-Lactams Breast Diseases |