drugset / Trial / NCT01505361

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

NCT01505361 ↗

Phase 1/2 Unknown 100 enrolled Universidad Complutense de Madrid
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2011-11
Primary completion
2012-03
Completion
2012-06

Outcome

Met primary endpoint

paper the percentage of women with mastitis in the probiotic group (25% [n = 14]) was significantly lower than in the control group (57% [n = 30]). PMID 26611780 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus salivarius PS2 Other / unclassified 9 unknown Oral

Indications