NCT01269554

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 26, 2021

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

November 13, 2010

Last Update Submit

May 25, 2021

Conditions

Diarrhea

Keywords

diarrheaGuinea-BissauFinlandChildrenAdultsIntestinal pathogensBacteriaVirusParasites

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (8)

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 Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Not willing or able to deliver the stool samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Postitalo Travel Clinic

Helsinki, 3448, Finland

Location

University of Helsinki

Helsinki, 3448, Finland

Location

Bandim Health Centre

Bissau, 1004 Bissau Codex, Guinea-Bissau

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecea samples are collected for analysis of patogens

MeSH Terms

Conditions

DiarrheaVirus Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2010

First Posted

January 4, 2011

Study Start

November 1, 2010

Primary Completion

May 1, 2013

Study Completion

July 1, 2015

Last Updated

May 26, 2021

Record last verified: 2015-08

Locations

FI(2)GU(1)