Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

May 22, 2009 updated by: Universidad Complutense de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Staphylococcal and/or streptococcal count in milk
Time Frame: 0 and 28 days
0 and 28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 25, 2009

Last Update Submitted That Met QC Criteria

May 22, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Promast08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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