Etiology of Diarrhea in Guinea-Bissau and in Finland

Completed

• Conditions: Diarrhea

• Registration Number: NCT01269554
• Lead Sponsor: Bandim Health Project

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-13
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2013-05
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

Postitalo Travel Clinic; 🇫🇮 Helsinki, Finland

University of Helsinki; 🇫🇮 Helsinki, Finland

Bandim Health Centre; 🇬🇼 Bissau, Guinea-Bissau