Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization

Universidad Complutense de Madrid100 enrolled

Overview

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Mastitis

Interventions

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Normal pregnancy * Healthy women * Lactational mastitis in, at least, a previous lactation period * No symptomatic vaginal infections Exclusion Criteria: * Any kind of health problems related to pregnancy * Symptomatic vaginal infections * Allergy to cow's milk protein * Intolerance to lactose * Antibiotic treatment

Outcomes

Primary Outcomes

Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts

Time frame: Weekly during the first 6 months after birth

Secondary Outcomes

Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab

Time frame: At weeks 30, 35, 40 of pregnancy