A Phase 1/2 interventional study of Lactobacillus salivarius PS2 and Excipient (milk powder) in Mastitis, sponsored by Universidad Complutense de Madrid. Status unknown at 1 site in Spain. Open to female participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-12.
Sponsored by Universidad Complutense de Madrid · Phase 1/2, Interventional, and Prevention
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.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's planned enrollment of 100 is below the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)
Biological: Lactobacillus salivarius PS2
Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)
Biological: Excipient (milk powder)
9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
100 mg/once a day from 30 week of pregnancy until birth
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
Time frame: Weekly during the first 6 months after birth
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab
Time frame: At weeks 30, 35, 40 of pregnancy
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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