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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269554
Other study ID # Diar-GB-Finland 2011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date July 2015

Study information

Verified date August 2015
Source Bandim Health Project
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 920
Est. completion date July 2015
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Postitalo Travel Clinic Helsinki
Finland University of Helsinki Helsinki
Guinea-Bissau Bandim Health Centre Bissau

Sponsors (3)

Lead Sponsor Collaborator
Bandim Health Project Stockholm University, University of Helsinki

Countries where clinical trial is conducted

Finland,  Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type of pathogens in stool samples in percentage of included patients The percentage of included patients with different pathogens will be described. 2 years
Secondary Type of microbes other than than pathogens in stool samples in percentage of included patients 2 years
Secondary The patern of resistance to antimicrobials in isolated pathogens 2 years
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