DiarrheaNCT01269554
Etiology of Diarrhea in Guinea-Bissau and in Finland
An observational study of Diarrhea, run by Bandim Health Project at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- How many people
- 920 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2010to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Not willing or able to deliver the stool samples
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Postitalo Travel Clinic
Helsinki, 3448
University of Helsinki
Helsinki, 3448
About this study
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
- Conditions
- Diarrhea
- Keywords
- diarrhea, Guinea-Bissau, Finland, Children, Adults, Intestinal pathogens, Bacteria, Virus, Parasites
- Medical subject headings
- Diarrhea, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with diarrhea in Bissau | Not described | |
| Children without diarrhea in Bissau | Not described | |
| Children without diarrhea in Finland | Not described | |
| Children with diarrhea in Finland | Not described | |
| Adults without diarrhea in Finland | Not described | |
| Adults with diarrhea in Finland | Not described | |
| Adults without diarrhea in Bissau | Not described | |
| Adults with diarrhea in Bissau | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of pathogens in stool samples in percentage of included patients
The percentage of included patients with different pathogens will be described.
Measured: 2 years
Secondary outcomes (2)
Type of microbes other than than pathogens in stool samples in percentage of included patients
Measured: 2 years
The patern of resistance to antimicrobials in isolated pathogens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Stockholm University
- Responsible party
- Sponsor
- Investigators
- Anu Kantele, Ph.d, Principal investigator, Helsinki University Central Hospital,Dept of Medicine, Division of Infectious Diseases, Aurora Hospital, Building 5, Floor 3, POB 3448, FIN-00029 HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269554
- Sponsor's protocol ID
- Diar-GB-Finland 2011
- Status last verified
- Aug 2015
- First submitted
- 13 Nov 2010
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Diarrhea in Guinea-Bissau and in Finland
- ClinicalTrials.gov ID
- NCT01269554
- Acronym / sponsor ID
- Diar-GB-Finland 2011
- Conditions
- Diarrhea
- Keywords
- diarrhea, Guinea-Bissau, Finland, Children, Adults, Intestinal pathogens, Bacteria, Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- University of Helsinki, Stockholm University
- Study start
- Nov 2010 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not willing or able to deliver the stool samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Kantele, Ph.d principal investigator
Helsinki University Central Hospital,Dept of Medicine, Division of Infectious Diseases, Aurora Hospital, Building 5, Floor 3, POB 3448, FIN-00029 HUS
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by Bandim Health Project at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of pathogens in stool samples in percentage of included patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.