Clinical trial

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

Name

2017-085

Description

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.

Trial arms

Trial start

2019-03-15

Estimated PCD

2021-09-21

Trial end

2021-09-21

Status

Completed

Treatment

blood sampling

5ml blood sampling

Arms:

Microbiological, anthropological and historical study

stool collection

self stool collection (2g)

Arms:

Microbiological, anthropological and historical study

Participatory activity and contact investigation

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

Arms:

Microbiological, anthropological and historical study

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.

Arms:

Microbiological, anthropological and historical study

Size

Primary endpoint

Percentage of gut bacterial genera shared by included people

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

Percentage of gut bacterial genera shared by selected wild animals

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

Percentage of gut bacterial genera shared by selected domesticated animals

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

Percentage of overlap (of viral genera) between human subjects and great apes

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

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-03-27

1 organization

3 products

1 indication

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Indication

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Product