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Comparative Study of Great Ape-caretaker Microbiome

NCT ID: NCT03282708

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2017-11-15

Brief Summary

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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

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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.

Conditions

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Human Intestinal Microbiome

Keywords

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intestinal microbiome captive great apes human beings

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Microbiome

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

Group Type EXPERIMENTAL

Fresh stool collection

Intervention Type OTHER

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

Data collection with self-administered questionnaire

Anthropology

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fresh stool collection

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

Data collection with self-administered questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Giles-Vernick, PhD

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

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Institut Pasteur

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ID-RCB: 2017-A00734-49

Identifier Type: OTHER

Identifier Source: secondary_id

2016-081

Identifier Type: -

Identifier Source: org_study_id