跳至主要内容
临床试验/NCT07450807
NCT07450807已完成不适用

Influence of Thymoquinone on the Human Gut Microbiome

Aysun Tekbaş1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年4月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Changes in bacterial taxa in fecal samples

研究概览

简要总结

For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life. The oil of the plant Nigella sativa (NS), a dietary supplement containing Thymoquinone (TQ) as its main active compound, exhibits hepatoprotective effects through antioxidative, antifibrotic, and anti-inflammatory properties, and also demonstrates anticancer and antiapoptotic activities. In vitro and in vivo studies have shown that TQ can also influence the gut microbiome. However, no clinical studies are currently available that describe the specific extent of TQ's influence on the human intestinal microbiome and its potential effects on the outcome after gastrointestinal surgery.

The aim of the project is therefore to investigate changes in the human microbiome following the intake of Nigella sativa seed oil capsules containing TQ as the main active ingredient. The study will test the hypothesis that TQ, through its diverse mechanisms of action, modulates the composition of the microbiome and thereby exerts a positive effect on immune response and intestinal healing processes. In parallel, TQ metabolites in urine will be analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) to gain insights into the pharmacokinetic profile of the compound.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no recent medication use
  • no history of gastrointestinal surgery
  • no pregnancy
  • no allergies to NSSO or its derivatives
  • 18 years and above

排除标准

  • regular medication
  • history of gastrointestinal surgery
  • pregnancy
  • allergies to NSSO or its derivates
  • presence of chronic illness
  • below the age of 18 years

研究组 & 干预措施

Treatment group

Experimental

Intake of two TQ-containing NSSO capsules three times daily for 20 days and fecal sampling at five time points.

干预措施: Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules (Dietary Supplement)

Control group

No Intervention

Fecal sampling at five time points without supplementation.

结局指标

主要结局

Changes in bacterial taxa in fecal samples

时间窗: From enrollment to the end of treatment at 20 days.

次要结局

未报告次要终点

研究者

发起方
Aysun Tekbaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aysun Tekbaş

Dr. med., MME

Jena University Hospital

研究点 (1)

Loading locations...

相似试验