A randomized, double-blind, placebo-controlled intervention study to assess the preventive effect of new probiotic strain on lactational mastitis.

utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 20950000 sites300 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000
Enrollment: 300
Status: Not yet recruiting
Last Updated: 2 years ago

ot applicable

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000

•\-Pre\-gravid body mass index (BMI)\<18 or \>30;
•\-Use of probiotic supplements during the third trimester of current pregnancy;
•\-Enhanced chance of premature delivery (before 37 weeks of gestation);
•\-Current or previous illnesses which could interfere with the study, like other mammary pathologies (e.g. abscesses, Raynaud¡¯s syndrome, breast cancer);
•\-Short bowel syndrome;
•\-Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation);
•\-Serious underlying disease predisposing to infection (e.g. HIV, auto\-immune diabetes, multiple organ failure, malignancy, severe burns, severe acute pancreatitis);
•\-Heart failure and cardiac medical history (e.g artificial heart valve, medical history of infectious endocarditis, rheumatic fever and cardiac malformation);
•\-History of aggressive immunosuppressive therapy (e.g. radiotherapy, cancer chemotherapy);
•\-Traumatic injury of the gastro\-intestinal tract;