跳至主要内容
临床试验/NCT03582826
NCT03582826已完成不适用

Dynamics of the Gut Microbiota in Idiopathic Malodor Production

Mebo Research, Inc.4 个研究点 分布在 2 个国家目标入组 125 人开始时间: 2018年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
4
主要终点
Gut Microbiome

研究概览

简要总结

The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.

详细描述

Human odorprints, mostly owing to the microbiome, have proven their value as biomarkers of health and environmental exposures. In recent years, microbial networks responsible for localized malodors such as halitosis or axillary odor have been mapped by using next generation sequencing approaches. Intestinal microbes responsible for psychologically debilitating systemic malodor (whole-body and extraoral halitosis), however, remain to be identified. Even a relatively straightforward disorder of choline metabolism trimethylaminuria (TMAU) is thought to exhibit complex host-gene microbiome interactions and has not been sufficiently studied.

Proposed controlled pilot study aims to explore the dynamics of microbial communities in remission and flare-up periods. Better knowledge of the important aspects of disease fluctuation should enhance patient care and, combined with our prior data, will help to develop new therapies and treatments.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • idiopathic malodor or PATM symptoms experienced over a period of several months or years
  • able to read and understand the study information
  • willing and able to comply with questionnaires, nutritional recommendations, and other study procedures

排除标准

  • consistent inability to communicate and process things related to their symptoms
  • consistent inability to distinguish physical symptoms from pure emotional reactions
  • lack of motivation to start feeling better

结局指标

主要结局

Gut Microbiome

时间窗: 1 year

Abundance \[operational taxonomic units\]

次要结局

  • Quality of Life [Score](1 year)
  • Change in Fecal Microbiome Composition Between Flare-ups and Improvements(1 year)
  • Idiopathic Malodor Episodes(1 year after study enrollment)
  • Alpha Diversity(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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