Global Effects of a Probiotic Strain on Lactating Women (PROBIOLAC)

Universidad Complutense de Madrid

Status: Completed

Conditions: Mastitis

Treatments: Biological: Lactobacillus salivarius PS2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01124448

PROBIOLAC

Details and patient eligibility

About

In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal term pregnancy
• Lactating women
• Healthy breastfed infant

Women with mastitis:

• Clinical symptoms of mastitis
• Painful breastfeeding
• Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
• Leukocyte count in milk higher 6 log10/mL

Women without mastitis:

• No clinical symptoms of mastitis
• No painful breastfeeding
• Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
• Leukocyte count in milk lower 5 log10/mL

Exclusion criteria

• Allergy to cow's milk protein
• Intolerance to lactose
• Antibiotic treatment
• Breast abscess
• Raynaud syndrome
• Any parallel disease

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Lactobacillus salivarius PS2

Experimental group

Description:

Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)

Treatment:

Biological: Lactobacillus salivarius PS2

Biological: Lactobacillus salivarius PS2

Lactobacillus salivarius PS2B

Active Comparator group

Description:

Lactating women without mastitis (n=15)

Treatment:

Biological: Lactobacillus salivarius PS2

Biological: Lactobacillus salivarius PS2