Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo

Zoonotic Disease Clinical Trial

— MICROTONE  

Official title:

Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012164
• Other study ID #: 2017-085
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: September 21, 2021

Study information

• Verified date: August 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Zoonotic Disease

Intervention

Biological:
• blood sampling
5ml blood sampling
• stool collection
self stool collection (2g)

Other:
• Participatory activity and contact investigation
30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months.
• Anthropological and historical interviews
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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	INRB	Kinshasa

Sponsors (4)

Lead Sponsor	Collaborator
Institut Pasteur	Centre National de la Recherche Scientifique, France, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, University Paris 7 - Denis Diderot

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of gut bacterial genera shared by included people	The investigators will evaluate the gut bacteria shared by humans on a daily basis.	2 years (March 13, 2019 to March 13, 2021)
Primary	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.	2 years (March 13, 2019 to March 13, 2021)
Primary	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.	2 years (March 13, 2019 to March 13, 2021)
Primary	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.	2 years (March 13, 2019 to March 13, 2021)
Secondary	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.	2 years (March 13,2019 to March 13, 2021)
Secondary	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.	2 years (March 13, 2019 to March 13, 2021)