Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Mastitis

Intervention / Treatment
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* Biological: Lactobacillus salivarius HN6
* Biological: Lactobacillus reuteri CR20
* Biological: Lactobacillus fermentum LC40
* Drug: Beta-lactam antibiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic 1<br>Women receiving Lactobacillus salivarius HN6 | Biological: Lactobacillus salivarius HN6<br>* 9 log colony-forming units, capsules, daily, four weeks<br>|
| Experimental: Probiotic 2<br>Women receiving Lactobacillus reuteri CR20 | Biological: Lactobacillus reuteri CR20<br>* 9 log colony-forming units, capsules, daily, four weeks<br>|
| Experimental: Probiotic 3<br>Women receiving Lactobacillus fermentum LC40 | Biological: Lactobacillus fermentum LC40<br>* 9 log colony-forming units, capsules, daily, four weeks<br>|
| Active Comparator: beta-lactam<br>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 | Drug: Beta-lactam antibiotic<br>* 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)<br>* Other names: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staphylococcal and/or streptococcal count in milk |  | 0 and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of local and systemic symptoms associated to mastitis |  | days 0, 7, 14 and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastitis, Staphylococcus, Streptococcus, lactation, breastfeeding