Etiology of Diarrhea in Guinea-Bissau and in Finland

NCT ID: NCT01269554

Last Updated: 2021-05-26

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

Total Enrollment

920 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-07-31

Brief Summary

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Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The majority of deaths are among children in developing countries, but the travellers encounter the disease as well. The studies on the aetiology have suffered from serious methodological deficiencies and the results are even controversial. At the same time, the current diagnostic methods are inadequate. The investigators have recently developed novel multiplex RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be collected from volunteers of different age groups and from healthy volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other intestinal microbes and antimicrobial resistance will be investigated

Detailed Description

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Conditions

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Diarrhea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with diarrhea in Bissau

No interventions assigned to this group

Children without diarrhea in Bissau

No interventions assigned to this group

Children without diarrhea in Finland

No interventions assigned to this group

Children with diarrhea in Finland

No interventions assigned to this group

Adults without diarrhea in Finland

No interventions assigned to this group

Adults with diarrhea in Finland

No interventions assigned to this group

Adults without diarrhea in Bissau

No interventions assigned to this group

Adults with diarrhea in Bissau

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Accepting to participate and willing to deliver 2 stool samples.
2. With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating.

Exclusion Criteria

* Not willing or able to deliver the stool samples
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Stockholm University

OTHER

Sponsor Role collaborator

Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anu Kantele, Ph.d

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Dept of Medicine, Division of Infectious Diseases, Aurora Hospital, Building 5, Floor 3, POB 3448, FIN-00029 HUS

Locations

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Postitalo Travel Clinic

Helsinki, , Finland

Site Status

University of Helsinki

Helsinki, , Finland

Site Status

Bandim Health Centre

Bissau, , Guinea-Bissau

Site Status

Countries

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Finland Guinea-Bissau

Other Identifiers

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Diar-GB-Finland 2011

Identifier Type: -

Identifier Source: org_study_id

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