Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Universidad Complutense de Madrid

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mastitis

Treatments: Biological: Lactobacillus fermentum LC40; Biological: Lactobacillus reuteri CR20; Drug: Beta-lactam antibiotic; Biological: Lactobacillus salivarius HN6

Study type: Interventional

Funder types: Other

Identifiers

NCT00716183

Promast08

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 19 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Probiotic 1

Experimental group

Description:

Women receiving Lactobacillus salivarius HN6

Treatment:

Biological: Lactobacillus salivarius HN6

Probiotic 2

Experimental group

Description:

Women receiving Lactobacillus reuteri CR20

Treatment:

Biological: Lactobacillus reuteri CR20

Probiotic 3

Experimental group

Description:

Women receiving Lactobacillus fermentum LC40

Treatment:

Biological: Lactobacillus fermentum LC40

beta-lactam

Active Comparator group

Description:

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

Treatment:

Drug: Beta-lactam antibiotic