跳至主要内容
临床试验/NL-OMON25986
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

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Interventional

研究者

发起方
utricia Research BVUppsalalaan 123508 TC UtrechtNederlandtel + 31 30 2095000

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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