Overview

This trial is active, not recruiting.

Condition diarrhea
Sponsor Bandim Health Project
Collaborator Helsinki University
Start date November 2010
End date May 2013
Trial size 800 participants
Trial identifier NCT01269554, Diar-GB-Finland 2011

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm

Primary Outcomes

Measure
Type of pathogens in stool samples in percentage of included patients
time frame: 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Etiology of Diarrhea in Guinea-Bissau and in Finland
Principal investigator Anu Kantele, Ph.d
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Bandim Health Project.