EUCTR2015-001763-39-PL进行中（未招募）1 期
E. coli Nissle 1917 - Suspension for infection prophylaxis; RONi-STUDY; The Multicentre, Prospective, Confirmatory, Randomised, Double-Blinded, Placebo- Controlled Phase IIIb Clinical Trial - RONi-STUDY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 558
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Signed informed consent form by the parents
- •- Age at first intake of trial medication: max. 120 hours after birth
- •- Functionally mature infant
- •- Gestational age more than 35th week of development
- •- Intention of the mother to breast feed the participant
- •- Readiness of the mother to administer no probiotics additionally to the trial medication to the participant during entire course of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 558
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Non-fulfilment of the at least one inclusion criteria
- •- Lack of propensity/ compliance of mother
- •- 5 min APGAR SCORE less than 5
- •- 10 min APGAR SCORE less than 8
- •- pH of umbilical cord blood less than 7*
- •* Determination not obligatory, if APGAR SCORES do not indicate that
- •the child may have suffered from a perinatal asphyxia.
- •- Any perinatal infection required antibiotic treatment
- •- Birth weight less than 2000 g
- •- TORCH-infection of the mother
- •- HIV-infection of the mother
- •- Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.
研究者
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