跳至主要内容
临床试验/NCT03925597
NCT03925597进行中(未招募)不适用

Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Stanford University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
2
主要终点
Mapping of microbiota changes in response to prebiotic intervention

研究概览

简要总结

The investigators propose a comprehensive, multiomic study that will integrate longitudinal data associating changes in specific gut bacteria and host in response to prebiotic fiber supplementation. These data will guide the development of an integrative biological signature relating bacterial-derived metabolites with biological outcome in the host. The open sharing of data generated by the proposed research represents a significant public resource that will support and accelerate future novel studies.

详细描述

Phenolics-rich prebiotic fiber has been correlated with a number of positive health outcomes, however their bioavailability is typically low. A large portion the gut microbiota metabolize these fibers releasing a range of phenolic acids, which are believed to be principle bioactive components driving reduction in disease risk. Despite this, little evidence exists linking specific gut bacteria with the metabolites they produce and the downstream biological effects that these compounds exert. With this study, the investigators propose to assemble a cohort of healthy individuals that will receive prebiotic supplementation, during comprehensive, longitudinal characterization of the microbiota and host changes with clinical markers and multiple omics assays. These multiomic data will then be integrated, generating unique biological signatures that define the role that microbial metabolites from specific bacteria play in host biological activity. To validate the biological function of these microbial metabolites, gnobiotic mice will be inoculated with the microbial strains identified. The newly identified metabolites will also be synthesized in vitro to demonstrate their structure, biological properties and applications. Through this study the investigators expect to gain a detailed and clear understanding of the physiological changes, at the mechanistic level, that occur in the microbiome and host in response to dietary supplementation with prebiotic fiber.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participant will be given the unlabeled fiber supplement.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • good general health

排除标准

  • Chronic inflammatory conditions
  • Major organ disease
  • Heavy alcohol use
  • Pregnancy/lactation
  • Use of medication known to affect carbohydrate or lipid metabolism
  • Active eating disorder

结局指标

主要结局

Mapping of microbiota changes in response to prebiotic intervention

时间窗: 3 years

A detailed map of microbes and microbial gene expression changes during the intervention will be developed. Microbiota complexity in fecal samples will be determined by shotgun metagenomic sequencing. Novel microbes and gene pathways will be identified by de novo assemble of whole fecal metagenomes.

Comprehensive phenotyping of host profile during prebiotic intervention

时间窗: 4 years

Changes in host (human) phenotypic profile during the prebiotic intervention will be determined. Profile will include the metagenome, transcriptome, metabolome and cytokines of participants during the prebiotic intervention.

Biological signatures identified from the integration of microbiome-host omes

时间窗: 4 years

Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Snyder

Chairman and Professor of Genetics

Stanford University

研究点 (2)

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