GE: Gastroenteritis in Pediatric Population of Qatar

• Sponsor: Hamad Medical Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03046342
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 32.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Gastroenteritis	Diagnostic Test: Molecular method (PCR)

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

• Study Type: Observational
• Anticipated Enrollment: 3000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Epidemiology of Acute Gastroenteritis in the Pediatric Population in Qatar: Causes, Risk Factors, Burden of Disease, Sources and Preventable Measures
• Actual Study Start Date: Mar 10, 2015
• Anticipated Primary Completion Date: Dec 10, 2022
• Anticipated Study Completion Date: Dec 10, 2022

Outcome Measures

Primary Outcome Measures

1. sources of viral, bacterial and parasitic GE in the country [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

Secondary Outcome Measures

1. seasonal variation of GE in qatar determination [4 years]

   seasonal variation of GE in qatar being determined by number of cases reported during each season

2. comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine [4 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All acute gastroenteritis patients between 3 months to 14 years presenting to PEC centers with acute diarrhea+/- vomiting with or without fever

Exclusion Criteria:

1. Cases of vomiting +/- fever only without diarrhea

2. Suspicion of surgical abdomen

3. Bile stained vomitus

4. Mal-absorption diseases as cystic fibrosis, celiac disease or increased secretion as disaccharides deficiency

5. Cases of Inflammatory bowel disease

6. Antibiotic associated diarrhea

7. Patients with immune deficiency

8. Patients with chronic diarrhea (>2 weeks of diarrhea)

9. Patients receiving long term medication for any disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamad medical corporation	Doha		Qatar	3050

Sponsors and Collaborators

• Hamad Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamad Medical Corporation
• ClinicalTrials.gov Identifier: NCT03046342
• Other Study ID Numbers: 14-00045
• First Posted: Feb 8, 2017
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hamad Medical Corporation: Gastroenteritis, Polymerase chain reaction
• Additional relevant MeSH terms: Gastroenteritis

Study Results

No Results Posted as of Mar 29, 2022