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

Study Overview
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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.

Official Title
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Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization

Conditions
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Mastitis

Intervention / Treatment
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* Biological: Lactobacillus salivarius PS2
* Biological: Excipient (milk powder)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth) | Biological: Lactobacillus salivarius PS2<br>* 9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth<br>|
| Placebo Comparator: Placebo<br>Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth) | Biological: Excipient (milk powder)<br>* 100 mg/once a day from 30 week of pregnancy until birth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts |  | Weekly during the first 6 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab |  | At weeks 30, 35, 40 of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, Lactobacillus salivarius, mastitis, prevention, group B streptococci, intrapartum prophylaxis