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

NCT ID: NCT04012164

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2021-09-21

Brief Summary

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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

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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

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Zoonotic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Microbiological, anthropological and historical study

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.

Group Type EXPERIMENTAL

blood sampling

Intervention Type BIOLOGICAL

5ml blood sampling

stool collection

Intervention Type BIOLOGICAL

self stool collection (2g)

Participatory activity and contact investigation

Intervention Type OTHER

30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months.

Anthropological and historical interviews

Intervention Type OTHER

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.

Interventions

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blood sampling

5ml blood sampling

Intervention Type BIOLOGICAL

stool collection

self stool collection (2g)

Intervention Type BIOLOGICAL

Participatory activity and contact investigation

30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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INRB

Kinshasa, , Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Other Identifiers

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2017-085

Identifier Type: -

Identifier Source: org_study_id

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