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Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis in the Absence of Diarrhea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05270291
Enrollment
198
Registered
2022-03-08
Start date
2022-05-01
Completion date
2024-12-31
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastroenteritis, Vomiting

Keywords

acute gastroenteritis, children, vomiting, enteropathogens

Brief 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.

Interventions

PROCEDURErectal swab

rectal swab

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.immediately after the procedure

Secondary

MeasureTime frame
Types of pathogens detected based on presenting symptomsimmediately after the procedure
The proportion of children with isolated vomiting with alternative diagnosisimmediately after procedure

Countries

Poland

Contacts

Primary ContactAleksandra Cepińska, MD
ocepinska@gmail.com223179444
Backup ContactAleksandra Cepińska

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026