Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

NCT05270291 | Unknown

• 1 other identifier: Isolated vomiting etiology
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis; Vomiting

Keywords

acute gastroenteritis; children; vomiting; enteropathogens

Outcome Measures

Primary Outcomes (1)

• The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

  immediately after the procedure

Secondary Outcomes (2)

• Types of pathogens detected based on presenting symptoms

  immediately after the procedure

• The proportion of children with isolated vomiting with alternative diagnosis

  immediately after procedure

Interventions

rectal swab PROCEDURE

rectal swab

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• age 0-5-year-old
• signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Mazovian, 02-091, Poland

RECRUITING

Related Publications (1)

• Cepinska A, Kolodziej M, Podsiadly E, Szajewska H. Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis in the Absence of Diarrhea: Protocol for a Cohort Study. JPGN Rep. 2022 Oct 25;3(4):e268. doi: 10.1097/PG9.0000000000000268. eCollection 2022 Nov.

  PMID: 37168472 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

rectal swabs

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aleksandra Cepińska, MD

CONTACT

223179444; ocepinska@gmail.com

Aleksandra Cepińska

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 8, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

PL (1)