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Completed

NCT Number: NCT04012164

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

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.

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Key information

Conditions

Zoonotic Disease Animal Diseases Infections Zoonoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INRB

Kinshasa, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

5ml blood sampling

stool collection

Biological

self stool collection (2g)

Participatory activity and contact investigation

Other

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

Anthropological and historical interviews

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Description of Contact type

    Time frame: 2 years (March 13,2019 to March 13, 2021)

    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. Contact frequency investigation

    Time frame: 2 years (March 13, 2019 to March 13, 2021)

    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.

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

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

Registry information

Acronym: MICROTONE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2019
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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