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临床试验/ACTRN12623000373673
ACTRN12623000373673招募中Unknown

Effect of heat-inactivated Lactobacillus sp. on sleep, stress and gastrointestinal health in adults with insomnia and elevated stress levels: a randomised, controlled trial

niversity of Otago0 个研究点目标入组 90 人开始时间: 2023年4月13日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
入组人数
90

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
18 Years 至 45 Years(—)
性别
All

入选标准

  • To be eligible to participate, people must meet both 1 and 2 of the following inclusion criteria:
  • 1)Experiencing sleep disturbances (difficulty getting to sleep, and/or staying asleep and/or waking too early over the last three months).
  • 2)Experiencing elevated stress

排除标准

  • - having a current clinical diagnosis of a sleep disorder (such as sleep apnea, sleep movement disorder or narcolepsy) or have had a recent major depressive episode or clincal diagnosis of schizophrenia, manic-depression or bipolar disorder
  • - taking prescribed medications for a sleep disorder or psychiatric disorder
  • - taken antibiotics wihtin the month before starting the trial
  • - medical history of severe gastrointestinal disorder (such as inflammatory bowel disease, coeliac disease) or clinically significant medical condition
  • - taking prescribed medications such as opioid pain killers, non-steroidal anti-inflammatory drugs
  • - are pregnant or lactating
  • - are current smokers
  • - have excessive alcohol intake (>21 standard drinks a week)
  • - unwilling to avoid probiotic or prebiotic supplements, or foods/beverages containing high levels of live lactic acid bacteria

研究者

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