Human Intestinal MicrobiomeSHAPES-CAPNCT03282708
Comparative Study of Great Ape-caretaker Microbiome
A study testing Fresh stool collection in people with Human Intestinal Microbiome, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Intestinal Microbiome
- What is being tested?
- Fresh stool collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2017to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Intestinal Microbiome
- Being tested
- Fresh stool collection
- Keywords
- intestinal microbiome, captive great apes, human beings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh stool collectionOther
One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).
Data collection with self-administered questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Fresh stool collection |
| Anthropology | No intervention | Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome comparison
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.
Measured: Three years (September 2017-September 2020)
Secondary outcomes (3)
Contact type investigation
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.
Measured: Three years (September 2017-September 2020)
Contact frequency investigation
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.
Measured: Three years (September 2017-September 2020)
Contact duration investigation
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.
Measured: Three years (September 2017-September 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start6 Nov 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Intestinal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamara Giles-Vernick, PhD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282708
- Sponsor's protocol ID
- 2016-081
- Other IDs
- ID-RCB: 2017-A00734-49
- Acronym
- SHAPES-CAP
- Status last verified
- Apr 2018
- First submitted
- 2 Aug 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Captive Great Ape and Human Intestinal Microbiomes
- ClinicalTrials.gov ID
- NCT03282708
- Acronym / sponsor ID
- SHAPES-CAP / 2016-081
- Conditions
- Human Intestinal Microbiome
- Keywords
- intestinal microbiome, captive great apes, human beings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Microbiome | Experimental | Other: Fresh stool collectionCaretakers 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 |
| Anthropology | No intervention | –Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For both Microbiome and Anthropology sub-study
- For Microbiome sub-study
- For Anthropology sub-study:
Key exclusion criteria (6 listed)
- For both Microbiome and Anthropology parts:
- For Microbiome sub-study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh stool collectionOne sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans). Data collection with self-administered questionnaire | Other | Microbiome |
Primary outcome
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.
3 secondary outcomes
Contact type investigation
Time frame: Three years (September 2017-September 2020)
Contact frequency investigation
Time frame: Three years (September 2017-September 2020)
Contact duration investigation
Time frame: Three years (September 2017-September 2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Giles-Vernick, PhD study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh stool collection in people with Human Intestinal Microbiome, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome comparison (time frame: Three years (September 2017-September 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.