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

NCT04012164 | Completed

• 1 other identifier: 2017-085
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Zoonotic Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Description of Contact type

  2 years (March 13,2019 to March 13, 2021)

• Contact frequency investigation

  2 years (March 13, 2019 to March 13, 2021)

Study Arms (1)

Microbiological, anthropological and historical study

EXPERIMENTAL

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

blood sampling BIOLOGICAL

5ml blood sampling

Microbiological, anthropological and historical study

stool collection BIOLOGICAL

self stool collection (2g)

Microbiological, anthropological and historical study

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.

Microbiological, anthropological and historical study

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.

Microbiological, anthropological and historical study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vulnerable adults 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.

Sponsors & Collaborators

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

Study Sites (1)

INRB

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Zoonoses

Interventions

Blood Specimen Collection; Contact Tracing

Condition Hierarchy (Ancestors)

Infections; Animal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: March 15, 2019
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: March 27, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)