Zoonotic DiseaseMICROTONENCT04012164
Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo
A study testing blood sampling, stool collection and Participatory activity and contact investigation in people with Zoonotic Disease, run by Institut Pasteur at 1 site in Democratic Republic of the Congo.
Trial summary
This study will evaluate the overlap between the intestinal microbiome and virome of wild and domesticated animals and human beings living in close proximity in three sites along an ecotone (ecological gradient) in the Democratic Republic of Congo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Zoonotic Disease
- What is being tested?
- blood sampling, stool collection and Participatory activity and contact investigation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 15 Mar 2019to 21 Sep 2021
- 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
- Age 18 years or older
- Accept participation in study
- Residing in one of three villages selected
- In good health and able to conduct habitual daily activities
- Accept self-collection of 2g of stool
- Accept blood collection (2-2.5 ml) by a medical professional
- Accept to self-collect daily activities and contacts with selected wild and domesticated animals for five months
- Accept to participate in an anthropological-historical interview on changing practices and contacts with wild and domesticated animals
Who cannot join
- Vulnerable adults will not be included
- Women who are pregnant or nursing at the time of recruitment and inclusion will not be included.
- Adults declaring themselves ill and unable to conduct their habitual daily activities will not be included.
- Adults with a chronic illness will not be included
- Adults who have a family member already included in the study will not be included.
- Adults refusing either recording of interviews or note-taking during interviews will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the overlap between the intestinal microbiome and virome of wild and domesticated animals and human beings living in close proximity in three sites along an ecotone (ecological gradient) in the Democratic Republic of Congo.
Read the detailed description
The MICROTONE study sheds light on zoonotic disease emergence by examining social and ecological pathways facilitating microbial and viral flows between people and selected wild and domesticated animals along a gradient of ecological change in a forest-savanna mosaic in the Democratic Republic of Congo, an epicenter of zoonotic disease emergence. The investigators analyze potential viral and bacterial overlap among humans and animals and explain this overlap (or not) through social sciences and ecological analyses of human and animal mobilities, practices and contacts. This multi-disciplinary, multi-species investigation in an ecotone (a transitional ecological zone linked to zoonotic disease emergence) offers a "pre-history" of spillover and emergence, tracing an ecological zeb of virome and microbial sharing among humans and animals. It will elucidate why such microbial and viral flows occur.
To conduct this investigation,there are two human sub-studies: the social sciences participatory study; and the clinical study. The clinical study will involve 30 human subjects from whom blood and stool samples will be collected. The social sciences participatory study will involve self-collected activity and animal contact data and oral interviews among 60 human subjects.
- Conditions
- Zoonotic Disease
- Being tested
- blood sampling, stool collection, Participatory activity and contact investigation, Anthropological and historical interviews
- Keywords
- microbiome, virome, zoonotic disease, ecological gradient, human-animal relations, anthropology, social sciences
- Medical subject headings
- Zoonoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
5ml blood sampling
stool collectionBiological
self stool collection (2g)
Participatory activity and contact investigationOther
30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months.
Anthropological and historical interviewsOther
Oral interviews on current and past practices and engagements with wild and domesticated animals will be conducted with the 30 human subjects who are recruited to self-report their activities (Participatory activity and contact investigation) and to provide blood and stool samples. Another 30 human subjects will be recruited only to participate in the same type of interviews, addressing past and present activities and relations with wild and domesticated animals.
| Study group | Role | What they receive |
|---|---|---|
| Microbiological, anthropological and historical study | Experimental | 30 adult participants will be recruited to self-report daily activities and contacts with domesticated and wild animals for a five month period. Following the five months of data collection, we will collect 5ml blood and 2g stool from each participant.
From the fifth month of investigation, an additional 30 adult participants will participate in oral anthropological, historical interviews to develop the socio-historical context of their changing activities and relations with selected domesticated and wild animals. No other intervention will be performed. Receives: Biological: blood sampling; Biological: stool collection; Other: Participatory activity and contact investigation; Other: Anthropological and historical interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of gut bacterial genera shared by included people
The investigators will evaluate the gut bacteria shared by humans on a daily basis.
Measured: 2 years (March 13, 2019 to March 13, 2021)
Percentage of gut bacterial genera shared by selected wild animals
The investigators will evaluate the gut bacteria shared by wild animals on a daily basis.
Measured: 2 years (March 13, 2019 to March 13, 2021)
Percentage of gut bacterial genera shared by selected domesticated animals
The investigators will evaluate the gut bacteria shared by domesticated animals living in proximity on a daily basis.
Measured: 2 years (March 13, 2019 to March 13, 2021)
Percentage of overlap (of viral genera) between human subjects and great apes
The percentage of overlap (of viral genera) between human subjects and great apes will be measured.
Measured: 2 years (March 13, 2019 to March 13, 2021)
Secondary outcomes (2)
Description of Contact type
The investigators will evaluate the type of physical contact between human beings, wild animals and domesticated animals from data collected in self-reported daily activity tool. This outcome will be measured through identified categories of physical contact. We will also estimate how contact types have changed over time through an analysis of the historical, anthropological interview data.
Measured: 2 years (March 13,2019 to March 13, 2021)
Contact frequency investigation
The investigators will evaluate the frequency of physical contact between human subjects and wild animals and domesticated animals from data collected in the self-reported daily activity collection tool. Frequency will be measured by the number per category of physical contact.
Measured: 2 years (March 13, 2019 to March 13, 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Mar 2019
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zoonotic DiseaseStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 2 types of participants. Human subjects participating in microbiological and anthropological study. Human subjects participating in historical and anthropological study, providing a larger context for those from whom we will collect biological samples and anthropological data
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Centre National de la Recherche Scientifique, France, University Paris 7 - Denis Diderot
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012164
- Sponsor's protocol ID
- 2017-085
- Acronym
- MICROTONE
- Status last verified
- Aug 2023
- First submitted
- 2 Jul 2019
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo
- ClinicalTrials.gov ID
- NCT04012164
- Acronym / sponsor ID
- MICROTONE / 2017-085
- Conditions
- Zoonotic Disease
- Keywords
- microbiome, virome, zoonotic disease, ecological gradient, human-animal relations, anthropology, social sciences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Centre National de la Recherche Scientifique, France, University Paris 7 - Denis Diderot
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 9 Jul 2019 (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.
This study will evaluate the overlap between the intestinal microbiome and virome of wild and domesticated animals and human beings living in close proximity in three sites along an ecotone (ecological gradient) in the Democratic Republic of Congo.
Detailed description
The MICROTONE study sheds light on zoonotic disease emergence by examining social and ecological pathways facilitating microbial and viral flows between people and selected wild and domesticated animals along a gradient of ecological change in a forest-savanna mosaic in the Democratic Republic of Congo, an epicenter of zoonotic disease emergence. The investigators analyze potential viral and bacterial overlap among humans and animals and explain this overlap (or not) through social sciences and ecological analyses of human and animal mobilities, practices and contacts. This multi-disciplinary, multi-species investigation in an ecotone (a transitional ecological zone linked to zoonotic disease emergence) offers a "pre-history" of spillover and emergence, tracing an ecological zeb of virome and microbial sharing among humans and animals. It will elucidate why such microbial and viral flows occur.
To conduct this investigation,there are two human sub-studies: the social sciences participatory study; and the clinical study. The clinical study will involve 30 human subjects from whom blood and stool samples will be collected. The social sciences participatory study will involve self-collected activity and animal contact data and oral interviews among 60 human subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 types of participants. Human subjects participating in microbiological and anthropological study. Human subjects participating in historical and anthropological study, providing a larger context for those from whom we will collect biological samples and anthropological data
| Arm | Type | Receives |
|---|---|---|
| Microbiological, anthropological and historical study | Experimental | Biological: blood sampling, Biological: stool collection, Other: Participatory activity and contact investigation, Other: Anthropological and historical interviews30 adult participants will be recruited to self-report daily activities and contacts with domesticated and wild animals for a five month period. Following the five months of data collection, we will collect 5ml blood and 2g stool from each participant. From the fifth month of investigation, an additional 30 adult participants will participate in oral anthropological, historical interviews to develop the socio-historical context of their changing activities and relations with selected domesticated and wild animals. No other intervention will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Accept participation in study
- Residing in one of three villages selected
- In good health and able to conduct habitual daily activities
- Accept self-collection of 2g of stool
Key exclusion criteria (6 listed)
- Vulnerable adults will not be included
- Women who are pregnant or nursing at the time of recruitment and inclusion will not be included.
- Adults declaring themselves ill and unable to conduct their habitual daily activities will not be included.
- Adults with a chronic illness will not be included
- Adults who have a family member already included in the study will not be included.
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 |
|---|---|---|
| blood sampling5ml blood sampling | Biological | Microbiological, anthropological and historical study |
| stool collectionself stool collection (2g) | Biological | Microbiological, anthropological and historical study |
| Participatory activity and contact investigation30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months. | Other | Microbiological, anthropological and historical study |
| Anthropological and historical interviewsOral interviews on current and past practices and engagements with wild and domesticated animals will be conducted with the 30 human subjects who are recruited to self-report their activities (Participatory activity and contact investigation) and to provide blood and stool samples. Another 30 human subjects will be recruited only to participate in the same type of interviews, addressing past and present activities and relations with wild and domesticated animals. | Other | Microbiological, anthropological and historical study |
Primary outcome
Percentage of gut bacterial genera shared by included people
Time frame: 2 years (March 13, 2019 to March 13, 2021)
The investigators will evaluate the gut bacteria shared by humans on a daily basis.
Percentage of gut bacterial genera shared by selected wild animals
Time frame: 2 years (March 13, 2019 to March 13, 2021)
The investigators will evaluate the gut bacteria shared by wild animals on a daily basis.
Percentage of gut bacterial genera shared by selected domesticated animals
Time frame: 2 years (March 13, 2019 to March 13, 2021)
The investigators will evaluate the gut bacteria shared by domesticated animals living in proximity on a daily basis.
Percentage of overlap (of viral genera) between human subjects and great apes
Time frame: 2 years (March 13, 2019 to March 13, 2021)
The percentage of overlap (of viral genera) between human subjects and great apes will be measured.
2 secondary outcomes
Description of Contact type
Time frame: 2 years (March 13,2019 to March 13, 2021)
Contact frequency investigation
Time frame: 2 years (March 13, 2019 to March 13, 2021)
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 27 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, stool collection and Participatory activity and contact investigation in people with Zoonotic Disease, run by Institut Pasteur at 1 site in Democratic Republic of the Congo.
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 27 Mar 2024. 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 Democratic Republic of the Congo. 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?
Percentage of gut bacterial genera shared by included people (time frame: 2 years (March 13, 2019 to March 13, 2021)). The study lists 4 primary outcomes in all. 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 27 Mar 2024.