Etiology of Diarrhea in Guinea-Bissau and in Finland

Sponsor

Bandim Health Project (Other)

Overall Status

Completed

CT.gov ID

NCT01269554

Collaborator

University of Helsinki (Other), Stockholm University (Other)

920

Enrollment

Locations

Actual Duration (Months)

306.7

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diarrhea

Study Design

Study Type:

Observational

Actual Enrollment :

920 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Etiology of Diarrhea in Guinea-Bissau and in Finland

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Children with diarrhea in Bissau
Children without diarrhea in Bissau
Children without diarrhea in Finland
Children with diarrhea in Finland
Adults without diarrhea in Finland
Adults with diarrhea in Finland
Adults without diarrhea in Bissau
Adults with diarrhea in Bissau

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Accepting to participate and willing to deliver 2 stool samples.
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Postitalo Travel Clinic	Helsinki	Finland	3448
2	University of Helsinki	Helsinki	Finland	3448
3	Bandim Health Centre	Bissau	Guinea-Bissau	1004 Bissau Codex

Sponsors and Collaborators

Bandim Health Project
University of Helsinki
Stockholm University

Investigators

Principal Investigator: Anu Kantele, Ph.d, Helsinki University Central Hospital,Dept of Medicine, Division of Infectious Diseases, Aurora Hospital, Building 5, Floor 3, POB 3448, FIN-00029 HUS