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临床试验/ACTRN12612000196842
ACTRN12612000196842已完成未知

A randomized placebo controlled trial of the effects of the probiotic Lactobacillus rhamnosus HN001 taken from the 1st trimester of pregnancy till 6 months post partum, if breastfeeding, on the development of eczema and atopic sensitization in infants by age 12 months.

Dr Kristin Wickens0 个研究点目标入组 400 人开始时间: 2012年2月15日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
400

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
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
16 Years 至 o limit(—)
性别
Female

入选标准

  • A woman will be eligible if 1. either they or the unborn child’s biological father has a history of asthma or eczema treated by a doctor or allergic rhinitis treated by a doctor or pharmacist (but excluding alternative, herbal or homeopathic medicine). 2. she is 14 to 16 weeks gestation 3. she intends to breastfeed 4. she speaks English

排除标准

  • A woman will be ineligible if she
  • 1. has a serious immunological disorder or is using immunomodulatory drugs
  • 2. is currently using or intends to use probiotic drinks or supplements in themselves or in their child
  • 3. is participating in another RCT
  • 4. has known cardiac vavle disease for which antibiotic prophylaxis is required if undergoing dental procedures
  • 5. required IVF to establish this pregnancy
  • 6. has a pre-enrolment scan showing fetal abnormalities
  • 7. does not agree to GP, midwife or hospital staff notification
  • 8. has a severe allergy to cow's milk that requires her to carry adrenalin
  • 9. has a history of transplant
  • 10. has a history of HIV
  • 11. is on continuous long-term antibiotics
  • 12. does not intend to stay in Wellington or Auckland for the next 18 months
  • 13. has miscarried since screening but prior to enrolment 14. is deemed unsuitable for study inclusion

研究者

发起方
Dr Kristin Wickens

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