Comparative Study of Great Ape-caretaker Microbiome (SHAPES-CAP)

April 27, 2018 updated by: Institut Pasteur

Comparative Study of Captive Great Ape and Human Intestinal Microbiomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75724
        • Institut Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: 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
No Intervention: Anthropology
Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Three years (September 2017-September 2020)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Three years (September 2017-September 2020)
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.
Three years (September 2017-September 2020)
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.
Three years (September 2017-September 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tamara Giles-Vernick, PhD, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-081
  • ID-RCB: 2017-A00734-49 (Other Identifier: French national registration number of the study)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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