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

Universidad Complutense de Madrid

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Mastitis

Treatments: Biological: Lactobacillus salivarius PS2; Biological: Excipient (milk powder)

Study type: Interventional

Funder types: Other

Identifiers

NCT01505361

PROBIOPREG

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)

Treatment:

Biological: Lactobacillus salivarius PS2

Placebo

Placebo Comparator group

Description:

Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)

Treatment:

Biological: Excipient (milk powder)