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临床试验/NCT04895774
NCT04895774Unknown不适用

Stool Collection From Healthy Donors for the ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota: Bacteria / Host Interaction Model

Nutri & Co0 个研究点目标入组 4 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4
主要终点
Quantity of Co2 production

研究概览

简要总结

To design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.

详细描述

The objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. These fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Person with a low fiber diet (<17g / day).

排除标准

  • Taking antibiotics and / or transit modulators in the 3 months preceding the sample;
  • Colonoscopy in the last 3 months;
  • Person under legal protection measure (curators, tutors, etc.).

结局指标

主要结局

Quantity of Co2 production

时间窗: Day 1 to Day 15

Change about the quantity of Co2 production after 15 days of incubation

PH evolution

时间窗: Day 1 to Day 15

Change about the PH evolution after 15 days of incubation

Bacterial growth

时间窗: Day 1 to Day 15

Change about the bacterial growth after 15 days of incubation

次要结局

未报告次要终点

研究者

发起方
Nutri & Co
申办方类型
Industry
责任方
Sponsor

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