Acute GastroenteritisNCT05270291
Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis
An observational study of Acute Gastroenteritis and Vomiting, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Acute Gastroenteritis, Vomiting
- What is being tested?
- rectal swab
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Aleksandra Cepińska contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Mazovian, 02-091
Aleksandra Cepińska, MD, 223179444, ocepinska@gmail.com
Maciej Kołodziej, PhD, 223179444
About this study
Official title: 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.
- Conditions
- Acute Gastroenteritis, Vomiting
- Being tested
- rectal swab
- Keywords
- acute gastroenteritis, children, vomiting, enteropathogens
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal swabProcedure or surgery
rectal swab
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.
Measured: immediately after the procedure
Secondary outcomes (2)
Types of pathogens detected based on presenting symptoms
Measured: immediately after the procedure
The proportion of children with isolated vomiting with alternative diagnosis
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 May 2022
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Szajewska, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270291
- Sponsor's protocol ID
- Isolated vomiting etiology
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37168472
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis in the Absence of Diarrhea
- ClinicalTrials.gov ID
- NCT05270291
- Acronym / sponsor ID
- Isolated vomiting etiology
- Conditions
- Acute Gastroenteritis, Vomiting
- Keywords
- acute gastroenteritis, children, vomiting, enteropathogens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectal swabrectal swab | Procedure or surgery | – |
Primary outcome
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.
Time frame: immediately after the procedure
2 secondary outcomes
Types of pathogens detected based on presenting symptoms
Time frame: immediately after the procedure
The proportion of children with isolated vomiting with alternative diagnosis
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 37168472Cepinska 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Cepińska contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroenteritis and Vomiting, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Cepińska, MD (223179444, ocepinska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified. (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.