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Completed

NCT Number: NCT03282708

Comparative Study of Great Ape-caretaker Microbiome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Pasteur

Paris, 75724, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresh stool collection

Other

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

Data collection with self-administered questionnaire

Primary outcomes

  1. Microbiome comparison

    Time frame: 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.

Secondary outcomes

  1. Contact type investigation

    Time frame: Three years (September 2017-September 2020)

    The investigators will evaluate the type of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured through identified categories of physical contact.

  2. Contact frequency investigation

    Time frame: Three years (September 2017-September 2020)

    The investigators will evaluate the frequency of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the number per category of physical contact.

  3. Contact duration investigation

    Time frame: Three years (September 2017-September 2020)

    The investigators will evaluate the duration of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the duration (time) per individual contact.

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Official study title

Comparative Study of Captive Great Ape and Human Intestinal Microbiomes

Acronym: SHAPES-CAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2017
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.