Etiology of Diarrhea in Guinea-Bissau and in Finland

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01269554

Enrollment

920

Registered

2011-01-04

Start date

2010-11-30

Completion date

2015-07-31

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

diarrhea, Guinea-Bissau, Finland, Children, Adults, Intestinal pathogens, Bacteria, Virus, Parasites

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Type of pathogens in stool samples in percentage of included patients	2 years	The percentage of included patients with different pathogens will be described.

Secondary

Measure	Time frame
Type of microbes other than than pathogens in stool samples in percentage of included patients	2 years
The patern of resistance to antimicrobials in isolated pathogens	2 years

Countries

Finland, Guinea-Bissau

Outcome results