Etiology of Diarrhea in Guinea-Bissau and in Finland

Diarrhea Clinical Trial

Official title:

Etiology of Diarrhea in Guinea-Bissau and in Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269554
• Other study ID #: Diar-GB-Finland 2011
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diarrhea

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