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临床试验/2022-500618-24-00
2022-500618-24-00招募中4 期

Prostate medication, metabolism and gut microbiota, PROMED.

Turku University Central Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月10日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
change of gut microbiota signature after two months of prostate medication (5-ARI, LhRH-analog/antagonist)

研究概览

简要总结

The general aim is to understand the interaction of prostate medical therapies and gut microbiota. Main objective is to investigate how prostate medical therapies (5-ARI, ADT) affect gut microbiota composition.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
性别
Male
接受健康志愿者

入选标准

  • histologically confirmed prostate cancer or benign prostate hyperplasia
  • provision of signed and dated informed consent form
  • ability and stated willingness to comply with all study procedures and availablity for the duration of the study
  • male aged >18 years

排除标准

  • inability to comply with study procedures or unwillingness to participate in the study
  • age < 18 years

结局指标

主要结局

change of gut microbiota signature after two months of prostate medication (5-ARI, LhRH-analog/antagonist)

change of gut microbiota signature after two months of prostate medication (5-ARI, LhRH-analog/antagonist)

次要结局

  • PSA response LhRH-analog/antagonist after 2 and 6 months of therapy
  • change of gut microbiota metabolism after two months of prostate medication (5-ARI, LhRH-analog/antagonist)
  • PSA response to 5-ARI after 2 and 6 months of therapy
  • prostate volume change to 5-ARI treatment after 2 and 6 months of therapy

研究者

发起方
Turku University Central Hospital
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Peter Boström

Scientific

Turku University Central Hospital

研究点 (1)

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