跳至主要内容
临床试验/NCT03282708
NCT03282708已完成不适用

Comparative Study of Captive Great Ape and Human Intestinal Microbiomes

Institut Pasteur1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Microbiome comparison

研究概览

简要总结

The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal microbiome shared by human beings and captive great apes living in proximity and in direct, daily contact. The investigators will determine the phylogenetic diversity of enterotypes (bacterial and viral) shared between human beings and great apes and will link these results with participant-observations of caretakers' activities (and contacts) with these great apes.

详细描述

The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal microbiome shared by human beings and captive great apes living in proximity and in direct, daily contact. The SHAPES-Captivity is an extension of the SHAPES study (financed by the ANR in 2014), currently ongoing in central Africa (Democratic Republic of Congo, Cameroon, Gabon). In Cameroon, the investigators have collected stool samples from gorillas, chimpanzees and human beings using the same forest space so as to conduct an analysis of the overlap of their intestinal microbiome. The results of this analysis will be interpreted in light of anthropological and geographical evidence collected among people living in this region. SHAPES-Captivity will enable the investigators to use the same approach but this time, under conditions of great ape captivity. The investigators will thus obtain data concerning intestinal microbiome overlap between captive great apes and human caretakers working in a controlled environment and in daily, direct contact. The SHAPES-Captivity study will provide a positive control, which will eventually be compared to results from the SHAPES study. Although multiple studies have investigated the overlap between human-great ape intestinal microbiome (Moeller et al. 2012 ; Moeller et al. 2016), none of these studies have investigated people living in close proximity to great apes, either in a natural or captive setting. The investigators will determine the phylogenetic diversity of enterotypes (bacterial and viral) shared between human beings and great apes, and will link these results with their participant-observations of caretakers' activities (and contacts) with these great apes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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
是

入选标准

  • •For both Microbiome and Anthropology sub-study
  • •Adult in good health
  • •Currently working as a caretakers of captive great apes
  • •For Microbiome sub-study
  • •Agree to autonomous collection of a stool sample
  • •Agree to return the stool specimen inside of a designated, supplied postal container and box.
  • •For Anthropology sub-study:
  • •Accept to be observed during his or her professional activity two times, each time for a duration of four hours by the researchers

排除标准

  • •For both Microbiome and Anthropology parts:
  • •Protected adults, pregnant and nursing mothers will not be included.
  • •For Microbiome sub-study
  • •Patients, especially those with gastrointestinal disorders (diarrhea), frequent and/or liquid stools, abdominal pain, nausea, vomiting, fever
  • •Anyone diagnosed with a chronic disease
  • •Anyone who has taken an antibiotic or antifungal treatment in the month preceding collection.

研究组 & 干预措施

Microbiome

Experimental

Caretakers of captive great apes. One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).

Data collection with self-administered questionnaire

干预措施: Fresh stool collection (Other)

Anthropology

No Intervention

Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes

结局指标

主要结局

Microbiome comparison

时间窗: Three years (September 2017-September 2020)

The investigators will evaluate the components of the intestinal microbiome (viral and bacterial enterotypes) shared by human caretakers and captive great apes living in proximity on a daily basis. The percentage of overlap (of viral and bacterial families) between human subjects and great apes will be measured.

次要结局

  • Contact type investigation(Three years (September 2017-September 2020))
  • Contact frequency investigation(Three years (September 2017-September 2020))
  • Contact duration investigation(Three years (September 2017-September 2020))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Comparative Study of Great Ape-caretaker Microbiome | 临床试验