Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00716183
• Date of registration: 14/07/2008
• Primary sponsor: Universidad Complutense de Madrid
• Public title: Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
• Scientific title: Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period
• Date of first enrolment: July 2008
• Target sample size: 300
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00716183
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Spain

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 38 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Mastitis

Intervention(s)

Biological: Lactobacillus fermentum LC40

Biological: Lactobacillus reuteri CR20

Biological: Lactobacillus salivarius HN6

Drug: Beta-lactam antibiotic

Primary Outcome(s)

Staphylococcal and/or streptococcal count in milk [Time Frame: 0 and 28 days]

Secondary Outcome(s)

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

Secondary ID(s)

Promast08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors