Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Mastitis
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Juan M. Rodríguez
Professor, PhD
Universidad Complutense de Madrid
Eligibility Criteria
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(At weeks 30, 35, 40 of pregnancy)