Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms

NCT07280624 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2025-12-12

No results posted yet for this study

Summary

This investigator-initiated randomized controlled trial compares the clinical impact of real time PCR of fecal samples in children with acute gastrointestinal symptoms at a pediatric emergency room. Specifically, the trial compares immediate testing of fecal samples using a multiplex PCR panel to a a control group with delayed test results.

Conditions

  • Gastroenteritis Acute
  • Gastrointestinal Symptoms
  • Abdominal Pain/ Discomfort
  • Vomiting in Infants and/or Children

Interventions

DIAGNOSTIC_TEST

Multiplex PCR gastrointestinal panel

Intervention includes a rapid use of multiplex PCR panel for gastrointestinal pathogens of fecal samples from children with acute gastrointestinal symptoms evaluated at a pediatric emergency room

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER
  • University of Oulu

    lead OTHER

Principal Investigators

  • Terhi S Ruuska-Loewald, MD, PhD · Oulu University Hospital and University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-15
Completion
2028-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280624 on ClinicalTrials.gov