Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

This study has been completed.
Sponsor:
Information provided by:
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT00716183
First received: July 14, 2008
Last updated: May 22, 2009
Last verified: May 2009
  Purpose

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
Mastitis
Biological: Lactobacillus salivarius HN6
Biological: Lactobacillus reuteri CR20
Biological: Lactobacillus fermentum LC40
Drug: Beta-lactam antibiotic
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   19 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716183

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT00716183     History of Changes
Other Study ID Numbers: Promast08
Study First Received: July 14, 2008
Last Updated: May 22, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Complutense de Madrid:
mastitis
Staphylococcus
Streptococcus
lactation
breastfeeding

Additional relevant MeSH terms:
Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Amoxicillin
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Cloxacillin
Lactams
Beta-Lactams
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014