Text Size

Etiology of Diarrhea in Guinea-Bissau and in Finland

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Helsinki University
Stockholm University
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01269554
First received: November 13, 2010
Last updated: March 16, 2013
Last verified: November 2012
History of Changes
  Purpose

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
Diarrhea

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The patern of resistance to antimicrobials in isolated pathogens [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269554

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

No publications provided

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01269554     History of Changes
Other Study ID Numbers: Diar-GB-Finland 2011
Study First Received: November 13, 2010
Last Updated: March 16, 2013
Health Authority: Guinea-Bissau: Instituto Nacional de Saúde Pública

Keywords provided by Bandim Health Project:
diarrhea
Guinea-Bissau
Finland
Children
Adults
 Intestinal pathogens
Bacteria
Virus
Parasites

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013