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Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716183
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : May 25, 2009
Information provided by:
Universidad Complutense de Madrid

Brief 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.

Condition or disease Intervention/treatment Phase
Mastitis Biological: Lactobacillus salivarius HN6 Biological: Lactobacillus reuteri CR20 Biological: Lactobacillus fermentum LC40 Drug: Beta-lactam antibiotic Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period
Study Start Date : July 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: Probiotic 1
Women receiving Lactobacillus salivarius HN6
Biological: Lactobacillus salivarius HN6
9 log colony-forming units, capsules, daily, four weeks

Experimental: Probiotic 2
Women receiving Lactobacillus reuteri CR20
Biological: Lactobacillus reuteri CR20
9 log colony-forming units, capsules, daily, four weeks

Experimental: Probiotic 3
Women receiving Lactobacillus fermentum LC40
Biological: Lactobacillus fermentum LC40
9 log colony-forming units, capsules, daily, four weeks

Active Comparator: beta-lactam
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
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)
Other Name: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine

Primary Outcome Measures :
  1. Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ]

Secondary Outcome Measures :
  1. Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716183

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Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juan M. Rodríguez, Universidad Complutense de Madrid Identifier: NCT00716183    
Other Study ID Numbers: Promast08
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 2009
Keywords provided by Universidad Complutense de Madrid:
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors