NL-OMON25986
尚未招募
不适用
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 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000
- 入组人数
- 300
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
ot applicable
研究者
入排标准
入选标准
- •Healthy pregnant, adults (\> 18 years of age);
- •\-Before/during the 35th week of pregnancy;
- •\-Intending to breastfeed her infant;
- •\-Written informed consent.
排除标准
- •\-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;
结局指标
主要结局
未指定
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