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Pilot Study of a Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Sponsor: Fu Jen Catholic University Hospital
Summary
This single-center, open-label, prospective pilot study aims to evaluate the feasibility, safety, and preliminary diagnostic performance of a minimally invasive gastric string sampling device combined with a rapid antigen assay for the detection of Helicobacter pylori infection. A total of 40 participants with documented \^13C-urea breath test (UBT) results will be enrolled, including 30 UBT-positive and 10 UBT-negative participants. All participants will undergo gastric mucus collection using a disposable string sampling device, followed by H. pylori rapid antigen testing. The primary objective is to assess the diagnostic sensitivity and specificity of the investigational test using \^13C-UBT as the reference standard. The secondary objective is to explore the correlation between the semi-quantitative test-line (T-line) color intensity of the rapid antigen assay and the corresponding UBT delta-over-baseline (DOB) values.
Official title: A Pilot Study Evaluating a Novel Minimally Invasive String-test and Rapid Antigen Assay for Helicobacter Pylori Detection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-12
Completion Date
2027-03
Last Updated
2026-10-30
Healthy Volunteers
Yes
Conditions
Interventions
HP String Test With Rapid Antigen Assay
Gastric mucus collection using a minimally invasive string test followed by Helicobacter pylori rapid antigen testing. The investigational test results will be compared with the participants' existing \^13C-UBT results as the reference standard to evaluate diagnostic agreement and preliminary diagnostic accuracy.
Locations (1)
Fu Jen Catholic University Hospital
New Taipei City, Taiwan, Taiwan