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 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年2月28日

试验速览

ot applicable

•-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;
•-Surgery, including dental surgery, within one month prior to inclusion (V1) ;
•-Investigator's uncertainty about the willingness/ability of the subject to comply with protocol requirements;
•-Participation in any other clinical trial within two weeks prior to entry into the study.

发起方

utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000