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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Mastitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic

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

Group Type EXPERIMENTAL

Lactobacillus salivarius PS2

Intervention Type BIOLOGICAL

9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth

Placebo

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

Group Type PLACEBO_COMPARATOR

Excipient (milk powder)

Intervention Type BIOLOGICAL

100 mg/once a day from 30 week of pregnancy until birth

Interventions

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Lactobacillus salivarius PS2

9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth

Intervention Type BIOLOGICAL

Excipient (milk powder)

100 mg/once a day from 30 week of pregnancy until birth

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes