Clinical trial NCT04012164: Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo
Official title: Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zoonotic Disease
Keywords: microbiome
virome
zoonotic disease
ecological gradient
human-animal relations
anthropology
social sciences
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Centre National de la Recherche Scientifique, France
name: University Paris 7 - Denis Diderot
First posted: 2019-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of gut bacterial genera shared by included people
timeFrame: 2 years (March 13, 2019 to March 13, 2021)
measure: Percentage of gut bacterial genera shared by selected wild animals
timeFrame: 2 years (March 13, 2019 to March 13, 2021)
measure: Percentage of gut bacterial genera shared by selected domesticated animals
timeFrame: 2 years (March 13, 2019 to March 13, 2021)
measure: Percentage of overlap (of viral genera) between human subjects and great apes
timeFrame: 2 years (March 13, 2019 to March 13, 2021)
Secondary outcomes:
measure: Description of Contact type
timeFrame: 2 years (March 13,2019 to March 13, 2021)
measure: Contact frequency investigation
timeFrame: 2 years (March 13, 2019 to March 13, 2021)
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: INRB
Study officials:
References: