GastroenteritisGENCT03046342
Gastroenteritis in Pediatric Population of Qatar
An observational study of Gastroenteritis, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in Pediatric population of Qatar Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Molecular method (PCR)
- How many people
- 3,000 participants
- Where
- 1 siteQatar
- Study dates
- 10 Mar 2015to 10 Dec 2024
- 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 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever
Who may be able to join
- All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever
Who cannot join
- Cases of vomiting +/- fever only without diarrhea
- Suspicion of surgical abdomen
- Bile stained vomitus
- Mal-absorption diseases as cystic fibrosis, celiac disease or increased secretion as disaccharides deficiency
- Cases of Inflammatory bowel disease
- Antibiotic associated diarrhea
Show all 9Show fewer
- Patients with immune deficiency
- Patients with chronic diarrhea (>2 weeks of diarrhea)
- Patients receiving long term medication for any disease
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad medical corporation
Doha, 3050
Dr.Khalid M Alansari, MD,FRCPC,FAAP(PEM), +97455336166 ext. +97444396006, KALANSARI1@hamad.qa
About this study
Official title: Epidemiology of Acute Gastroenteritis in the Pediatric Population in Qatar: Causes, Risk Factors, Burden of Disease, Sources and Preventable Measures
Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in Pediatric population of Qatar
Read the detailed description
Processing of stool samples by molecular method (PCR) for children with GE including complete data collection. Patients are followed up for 14 days
- Conditions
- Gastroenteritis
- Being tested
- Molecular method (PCR)
- Keywords
- Gastroenteritis, Polymerase chain reaction
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular method (PCR)Diagnostic test
Stool samples are being processed through molecular method (PCR) for children with GE.
Epidemiology of acute Gastroenteritis in the pediatric population in Qatar
What is being measured
The primary outcome is the main question the study is designed to answer.
sources of viral, bacterial and parasitic GE in the country
Prevalence of viral, bacterial and parasitic GE in children < 14 years of age in Qatar will be identified by molecular method sample processing
Measured: 4 years
Secondary outcomes (2)
seasonal variation of GE in qatar determination
seasonal variation of GE in qatar being determined by number of cases reported during each season
Measured: 4 years
comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine
comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine by detection of source of GE in vaccinated children by molecular method.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start10 Mar 2015
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046342
- Sponsor's protocol ID
- 14-00045
- Acronym
- GE
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2017
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Acute Gastroenteritis in the Pediatric Population in Qatar: Causes, Risk Factors, Burden of Disease, Sources and Preventable Measures
- ClinicalTrials.gov ID
- NCT03046342
- Acronym / sponsor ID
- GE / 14-00045
- Conditions
- Gastroenteritis
- Keywords
- Gastroenteritis, Polymerase chain reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 8 Feb 2017 (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.
Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in Pediatric population of Qatar
Detailed description
Processing of stool samples by molecular method (PCR) for children with GE including complete data collection. Patients are followed up for 14 days
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever
Key inclusion criteria (1 listed)
- All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever
Key exclusion criteria (9 listed)
- Cases of vomiting +/- fever only without diarrhea
- Suspicion of surgical abdomen
- Bile stained vomitus
- Mal-absorption diseases as cystic fibrosis, celiac disease or increased secretion as disaccharides deficiency
- Cases of Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular method (PCR)Stool samples are being processed through molecular method (PCR) for children with GE. Epidemiology of acute Gastroenteritis in the pediatric population in Qatar | Diagnostic test | – |
Primary outcome
sources of viral, bacterial and parasitic GE in the country
Time frame: 4 years
Prevalence of viral, bacterial and parasitic GE in children < 14 years of age in Qatar will be identified by molecular method sample processing
2 secondary outcomes
seasonal variation of GE in qatar determination
Time frame: 4 years
comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Khalid Alansari (+974 55336166, kalansari1@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sources of viral, bacterial and parasitic GE in the country (time frame: 4 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 22 Mar 2024.