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Etiology of Diarrhea in Guinea-Bissau and in Finland

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
Helsinki University
Stockholm University
Information provided by (Responsible Party):
Bandim Health Project Identifier:
First received: November 13, 2010
Last updated: March 10, 2014
Last verified: March 2014
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


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Etiology of Diarrhea in Guinea-Bissau and in Finland

Resource links provided by NLM:

Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Type of pathogens in stool samples in percentage of included patients [ Time Frame: 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 [ Time Frame: 2 years ]
  • The patern of resistance to antimicrobials in isolated pathogens [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Faecea samples are collected for analysis of patogens

Estimated Enrollment: 800
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. children and adults with diarrhea reporting to Bandim Health Centre
  2. age and sex mached children and adults without diarrhea from Bandim
  3. children and adults with a recent travel history and suffering from diarrhea reporting to Postitalo Travel Clinic
  4. children and adults without diarrhea and no recent travel history reporting to Postitalo Travel Clinic

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01269554

Postitalo Travel Clinic
Helsinki, Finland, 3448
University of Helsinki
Helsinki, Finland, 3448
Bandim Health Centre
Bissau, Guinea-Bissau, 1004 Bissau Codex
Sponsors and Collaborators
Bandim Health Project
Helsinki University
Stockholm University
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
  More Information

Responsible Party: Bandim Health Project Identifier: NCT01269554     History of Changes
Other Study ID Numbers: Diar-GB-Finland 2011
Study First Received: November 13, 2010
Last Updated: March 10, 2014

Keywords provided by Bandim Health Project:
Intestinal pathogens

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on April 28, 2017