Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Phase 2

Completed

• Conditions: Mastitis
• Interventions: Biological: Lactobacillus salivarius HN6; Biological: Lactobacillus reuteri CR20; Biological: Lactobacillus fermentum LC40; Drug: Beta-lactam antibiotic

• Registration Number: NCT00716183
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-22
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic 1	Lactobacillus salivarius HN6	Women receiving Lactobacillus salivarius HN6
Probiotic 2	Lactobacillus reuteri CR20	Women receiving Lactobacillus reuteri CR20
Probiotic 3	Lactobacillus fermentum LC40	Women receiving Lactobacillus fermentum LC40
beta-lactam	Beta-lactam antibiotic	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

Primary Outcome Measures

Name	Time	Method
Staphylococcal and/or streptococcal count in milk	0 and 28 days

Secondary Outcome Measures

Name	Time	Method
Assessment of local and systemic symptoms associated to mastitis	days 0, 7, 14 and 28

Trial Locations

Locations (1)

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos; 🇪🇸 Madrid, Spain