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

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.

Study Overview

• Status: Recruiting
• Conditions: Vomiting; Acute Gastroenteritis
• Intervention / Treatment: Procedure: rectal swab

• Study Type: Observational
• Enrollment (Anticipated): 198

Contacts and Locations

• Study Contact: Name: Aleksandra Cepińska, MD; Phone Number: 223179444; Email: ocepinska@gmail.com
• Study Contact Backup: Name: Aleksandra Cepińska

Study Locations

• Poland
  • Mazovian
    • Warsaw, Mazovian, Poland, 02-091
      • Recruiting
      • Medical University of Warsaw
      • Contact: Aleksandra Cepińska, MD; Phone Number: 223179444; Email: ocepinska@gmail.com
      • Contact: Maciej Kołodziej, PhD; Phone Number: 223179444

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: children; vomiting; acute gastroenteritis; enteropathogens
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Vomiting; Gastroenteritis
• Other Study ID Numbers: Isolated vomiting etiology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No