Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

  • STATUS
    Recruiting
  • End date
    Dec 14, 2024
  • participants needed
    198
  • sponsor
    Medical University of Warsaw
Updated on 14 July 2022
diarrhea
acute gastroenteritis

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.

Details
Condition Acute Gastroenteritis, Vomiting
Treatment Rectal swab
Clinical Study IdentifierNCT05270291
SponsorMedical University of Warsaw
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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 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, cystic fibrosis, coeliac disease
immunodeficiency
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note