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CompletedNCT04012164MICROTONEUpdated Mar 27, 2024

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

An interventional study of blood sampling and stool collection in Zoonotic Disease, sponsored by Institut Pasteur. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Institut Pasteur · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2019, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Zoonotic Disease

Keywords

  • microbiome
  • virome
  • zoonotic disease
  • ecological gradient
  • human-animal relations
  • anthropology
  • social sciences
03

In context

Lead sponsor

Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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.

    Biological: blood sampling · Biological: stool collection · Other: Participatory activity and contact investigation · Other: Anthropological and historical interviews

Interventions

  • Biologicalblood sampling

    5ml blood sampling

  • Biologicalstool collection

    self stool collection (2g)

  • OtherParticipatory activity and contact investigation

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

  • OtherAnthropological 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.

06

What researchers measure

Primary outcomes

  1. Percentage of gut bacterial genera shared by included people

    The investigators will evaluate the gut bacteria shared by humans on a daily basis.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 site
  • INRB
    Kinshasa, Congo, The Democratic Republic of the
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04012164
Lead sponsor
Institut Pasteur
Collaborators
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Centre National de la Recherche Scientifique, France, University Paris 7 - Denis Diderot
Responsible party
Sponsor
First posted
Jul 9, 2019
Start date
Mar 15, 2019
Primary completion
Sep 21, 2021
Completion
Sep 21, 2021
Last update
Mar 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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