Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

Last updated: June 27, 2022
Sponsor: Medical University of Warsaw
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vomiting

Gastroenteritis

Treatment

N/A

Clinical Study ID

NCT05270291
Isolated vomiting etiology
  • Ages < 5
  • All Genders

Study Summary

In children with acute gastroenteritis (AGE), vomiting often precedes diarrhea. To establish the diagnosis of AGE, enteropathogen detection typically relies on diarrheal stool samples. However, testing requires sufficient stool sample, which may not be easily available. Recent studies suggest that in children presenting to emergency departments with presumed AGE with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. The rate of enteropathogen detection in children with isolated vomiting due to AGE may differ in various populations. Using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

This will be a prospective cohort study. Children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed AGE, lasting no longer than 7 days before enrolment, will be recruited. A total of 198 participants will be recruited and a rectal swab will be collected. The participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 0-5-year-old
  • presence of ≥3 episodes of vomiting due to presumed AGE at inclusion
  • <7 days of symptoms at the time of inclusion
  • signed written informed consent

Exclusion

Exclusion Criteria:

  • anticipated inability to complete 14 days follow-up
  • history of neutropenia (as rectal swabs are contraindicated)
  • critically ill status requiring urgent medical intervention
  • inability to provide a rectal swab for testing
  • chronic gastrointestinal tract disorders such as inflammatory bowel disease, cysticfibrosis, coeliac disease
  • immunodeficiency

Study Design

Total Participants: 198
Study Start date:
May 01, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Medical University of Warsaw

    Warsaw, Mazovian 02-091
    Poland

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.