NCT03046342

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 10, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

March 22, 2024

Status Verified

February 1, 2023

Enrollment Period

9.5 years

First QC Date

January 31, 2017

Last Update Submit

March 21, 2024

Conditions

Keywords

Gastroenteritis, Polymerase chain reaction

Outcome Measures

Primary Outcomes (1)

  • 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

    4 years

Secondary Outcomes (2)

  • seasonal variation of GE in qatar determination

    4 years

  • comparing the prevalence of viral GE in vaccinated children in Qatar (against rotavirus) and the other countries which implemented rotavirus vaccine

    4 years

Interventions

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

Eligibility Criteria

Age3 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • Patients with immune deficiency
  • Patients with chronic diarrhea (\>2 weeks of diarrhea)
  • Patients receiving long term medication for any disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad medical corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Dr.Khalid Alansari

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 8, 2017

Study Start

March 10, 2015

Primary Completion

September 10, 2024

Study Completion

December 10, 2024

Last Updated

March 22, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations