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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014