ACTRN12613000368730尚未招募1 期
A randomised double blind, placebo-controlled trial to evaluate the efficacy of a probiotic adjuvant in enhancing vaccine immune responses in healthy infants aged 3-7 months.
Associate Professor Mimi Tang0 个研究点目标入组 30 人开始时间: 2013年4月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 4 Weeks 至 7 Months（—）
- 性别
- All
入选标准
- •1) Healthy, term infants (post-delivery) will be recruited from the postnatal maternity ward at the Royal Women's Hospital, Melbourne.
- •2 )The infant must be 4 weeks of age.
- •3) The infant must be born via a vaginal birth at 37 weeks or greater gestation.
- •4) The mother cannot have been on antibiotic treatment 2 weeks prior to delivery.
排除标准
- •1) Mothers who were taking probiotics during pregnancy or are on probiotic supplements.
- •2) Mothers who have a proven or suspected immunodeficiency.
- •3) Infants must not have had a probiotic.
- •4) Infants who have a significant foetal abnormality.
- •5) Infants who have or a proven or suspected immunodeficiency.
- •6)Significant maternal illness or disability such that study participation would impose an unacceptable additional burden.
- •7) Planning or likely to leave the area before the study finishes.
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