Clinical trial NCT03282708: Comparative Study of Great Ape-caretaker Microbiome
Official title: Comparative Study of Captive Great Ape and Human Intestinal Microbiomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Intestinal Microbiome
Keywords: intestinal microbiome
captive great apes
human beings
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 group of caretakers (9 volunteers). For this group: one sample collection of spontaneously produced fresh stools (of the approximate size of 3 green beans);

1 group of caretakers (8 volunteers). For this group: no intervention (participant-observation only)
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Microbiome comparison
timeFrame: Three years (September 2017-September 2020)
Secondary outcomes:
measure: Contact type investigation
timeFrame: Three years (September 2017-September 2020)
measure: Contact frequency investigation
timeFrame: Three years (September 2017-September 2020)
measure: Contact duration investigation
timeFrame: Three years (September 2017-September 2020)
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Pasteur
Study officials:
affiliation: Institut Pasteur
name: Tamara Giles-Vernick, PhD
role: STUDY_DIRECTOR
References: