Helicobacter PyloriNCT07906938
Pilot Study of a Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
A study testing HP String Test With Rapid Antigen Assay in people with Helicobacter Pylori, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- HP String Test With Rapid Antigen Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years.
- Completed a 13C-urea breath test (UBT) within 28 days prior to enrollment, with documented test results.
- Able to understand the study procedures and willing to provide written informed consent.
Who cannot join
- History of dysphagia, esophageal stricture, or gastrointestinal obstruction.
- Use of antibiotics, bismuth-containing agents, or proton pump inhibitors (PPIs) within 4 weeks prior to enrollment, as these medications may affect H. pylori antigen detection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Fu Jen Catholic University Hospital
New Taipei City, Taiwan, 24352
Yu-tse Chiu, MD, +886912410603, b95401030@gmail.com
Yu-tse Chiu, MD
About this study
Official title: A Pilot Study Evaluating a Novel Minimally Invasive String-test and Rapid Antigen Assay for Helicobacter Pylori Detection
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.
Read the detailed description
Background and Rationale
Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Commonly used non-invasive diagnostic methods include the ^13C-urea breath test (UBT) and stool antigen testing. Although these methods are widely used, stool-based testing requires specimen collection and handling, while UBT generally requires specialized analytical equipment.
A minimally invasive gastric string sampling device may provide an alternative approach for obtaining gastric specimens without conventional upper gastrointestinal endoscopy. Combining this sampling method with a rapid antigen assay may offer a convenient approach for H. pylori detection. However, the diagnostic performance of this combination using string-collected gastric mucus has not yet been established.
Study Design
This is a single-center, open-label, prospective pilot diagnostic accuracy study conducted at Fu Jen Catholic University Hospital, Taiwan.
A total of 40 participants aged 18-75 years with documented ^13C-UBT results obtained within 28 days before enrollment will be recruited. An enriched enrollment strategy will be adopted to include approximately 30 UBT-positive and 10 UBT-negative participants.
All participants will undergo the same investigational procedure. The previously obtained ^13C-UBT results will serve as the reference standard for evaluating diagnostic performance.
Investigational Procedure
The investigational procedure combines two medical devices:
Disposable Gastric Specimen Collection String: A minimally invasive gastric sampling device distributed by POCT Biotech Co., Ltd. (CE-certified, CE No. 6976663940137), used to collect gastric mucus specimens.
Helicobacter pylori Rapid Antigen Test: A rapid antigen assay manufactured by Strong Biotech Co., Ltd. (Taiwan Food and Drug Administration Medical Device License No. 007277), used to detect H. pylori antigens in the collected specimens.
The use of string-collected gastric mucus with this rapid antigen assay represents an investigational application. Results obtained from the investigational procedure will be used exclusively for research purposes and will not guide clinical diagnosis or treatment decisions.
Study Procedures
- Gastric Specimen Collection Participants will fast overnight before the study procedure. Each participant will swallow a disposable gastric specimen collection capsule with approximately 250 mL of water. After the capsule dissolves, the attached string will remain in the stomach for approximately 60 minutes to absorb gastric mucus. The string will subsequently be retrieved by trained study personnel.
- Rapid Antigen Testing The retrieved string will be immersed in the designated antigen extraction buffer. The extracted specimen will then be applied to the H. pylori rapid antigen test cassette, and the result will be interpreted after the specified reaction time of approximately 3-5 minutes.
- Test Result Interpretation
Qualitative test results will be recorded as positive or negative. In addition, two independent investigators blinded to the participants' UBT results will assess the test-line (T-line) color intensity using a standardized reference chart, assigning a semi-quantitative score ranging from 0 to 4.
Outcome Assessments
Primary Outcome
The primary outcome is the diagnostic performance of the investigational test, assessed by sensitivity and specificity using ^13C-UBT as the reference standard. A UBT delta-over-baseline (DOB) value of ≥4.0 will be considered positive, whereas a value below 4.0 will be considered negative.
Secondary Outcome
The secondary outcome is the correlation between the semi-quantitative T-line color intensity score and the corresponding ^13C-UBT DOB value, assessed using Spearman's rank correlation coefficient.
Safety Assessment
Participant discomfort during capsule swallowing, gastric retention, and string retrieval will be evaluated using a Visual Analog Scale (VAS).
Adverse events potentially associated with the investigational procedure, including nausea, gagging, throat discomfort, mucosal irritation or injury, bleeding, and difficulty retrieving the string, will be monitored and documented.
If clinically significant adverse events occur, appropriate medical evaluation and management will be provided according to institutional clinical practice. Serious adverse events will be reported to the Institutional Review Board in accordance with applicable regulations.
- Conditions
- Helicobacter Pylori
- Being tested
- HP String Test With Rapid Antigen Assay
- Keywords
- Helicobacter pylori, Antigens, Bacterial, Point-of-Care Testing, Sensitivity and Specificity, Diagnostic Techniques and Procedures, String Test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP String Test With Rapid Antigen AssayDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| HP String Test With Rapid Antigen Assay | Experimental | Not described Receives: Diagnostic Test: HP String Test With Rapid Antigen Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity and Specificity of the HP String Test With Rapid Antigen Assay
Diagnostic sensitivity and specificity of the gastric string test combined with a rapid antigen assay for detecting Helicobacter pylori infection, using the ^13C-urea breath test (UBT) as the reference standard (DOB ≥4.0 indicating a positive result and DOB <4.0 indicating a negative result).
Measured: At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Secondary outcomes (1)
Correlation Between T-Line Color Intensity and ^13C-UBT DOB Values
The correlation between the test-line (T-line) color intensity of the gastric string test combined with a rapid antigen assay, graded on a standardized 0-4 ordinal scale, and the corresponding ^13C-urea breath test (UBT) delta-over-baseline (DOB) values will be assessed.
Measured: At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, open-label, prospective pilot diagnostic accuracy study employing a single-group assignment model. All 40 participants, including 30 with positive and 10 with negative \^13C-urea breath test (UBT) results, will undergo the same investigational procedure, consisting of 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SUPREME ELECTRONICS CO., LTD., POCT BIOTECHNOLOGY CO., LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906938
- Sponsor's protocol ID
- FJUH115665
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with external researchers to protect participant confidentiality and comply with institutional data protection policies. Only aggregated study results and findings published in scientific journals will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating a Novel Minimally Invasive String-test and Rapid Antigen Assay for Helicobacter Pylori Detection
- ClinicalTrials.gov ID
- NCT07906938
- Acronym / sponsor ID
- FJUH115665
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter pylori, Antigens, Bacterial, Point-of-Care Testing, Sensitivity and Specificity, Diagnostic Techniques and Procedures, String Test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Collaborators
- SUPREME ELECTRONICS CO., LTD., POCT BIOTECHNOLOGY CO., LTD.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
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.
Detailed description
Background and Rationale
Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Commonly used non-invasive diagnostic methods include the ^13C-urea breath test (UBT) and stool antigen testing. Although these methods are widely used, stool-based testing requires specimen collection and handling, while UBT generally requires specialized analytical equipment.
A minimally invasive gastric string sampling device may provide an alternative approach for obtaining gastric specimens without conventional upper gastrointestinal endoscopy. Combining this sampling method with a rapid antigen assay may offer a convenient approach for H. pylori detection. However, the diagnostic performance of this combination using string-collected gastric mucus has not yet been established.
Study Design
This is a single-center, open-label, prospective pilot diagnostic accuracy study conducted at Fu Jen Catholic University Hospital, Taiwan.
A total of 40 participants aged 18-75 years with documented ^13C-UBT results obtained within 28 days before enrollment will be recruited. An enriched enrollment strategy will be adopted to include approximately 30 UBT-positive and 10 UBT-negative participants.
All participants will undergo the same investigational procedure. The previously obtained ^13C-UBT results will serve as the reference standard for evaluating diagnostic performance.
Investigational Procedure
The investigational procedure combines two medical devices:
Disposable Gastric Specimen Collection String: A minimally invasive gastric sampling device distributed by POCT Biotech Co., Ltd. (CE-certified, CE No. 6976663940137), used to collect gastric mucus specimens.
Helicobacter pylori Rapid Antigen Test: A rapid antigen assay manufactured by Strong Biotech Co., Ltd. (Taiwan Food and Drug Administration Medical Device License No. 007277), used to detect H. pylori antigens in the collected specimens.
The use of string-collected gastric mucus with this rapid antigen assay represents an investigational application. Results obtained from the investigational procedure will be used exclusively for research purposes and will not guide clinical diagnosis or treatment decisions.
Study Procedures
- Gastric Specimen Collection Participants will fast overnight before the study procedure. Each participant will swallow a disposable gastric specimen collection capsule with approximately 250 mL of water. After the capsule dissolves, the attached string will remain in the stomach for approximately 60 minutes to absorb gastric mucus. The string will subsequently be retrieved by trained study personnel.
- Rapid Antigen Testing The retrieved string will be immersed in the designated antigen extraction buffer. The extracted specimen will then be applied to the H. pylori rapid antigen test cassette, and the result will be interpreted after the specified reaction time of approximately 3-5 minutes.
- Test Result Interpretation
Qualitative test results will be recorded as positive or negative. In addition, two independent investigators blinded to the participants' UBT results will assess the test-line (T-line) color intensity using a standardized reference chart, assigning a semi-quantitative score ranging from 0 to 4.
Outcome Assessments
Primary Outcome
The primary outcome is the diagnostic performance of the investigational test, assessed by sensitivity and specificity using ^13C-UBT as the reference standard. A UBT delta-over-baseline (DOB) value of ≥4.0 will be considered positive, whereas a value below 4.0 will be considered negative.
Secondary Outcome
The secondary outcome is the correlation between the semi-quantitative T-line color intensity score and the corresponding ^13C-UBT DOB value, assessed using Spearman's rank correlation coefficient.
Safety Assessment
Participant discomfort during capsule swallowing, gastric retention, and string retrieval will be evaluated using a Visual Analog Scale (VAS).
Adverse events potentially associated with the investigational procedure, including nausea, gagging, throat discomfort, mucosal irritation or injury, bleeding, and difficulty retrieving the string, will be monitored and documented.
If clinically significant adverse events occur, appropriate medical evaluation and management will be provided according to institutional clinical practice. Serious adverse events will be reported to the Institutional Review Board in accordance with applicable regulations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, open-label, prospective pilot diagnostic accuracy study employing a single-group assignment model. All 40 participants, including 30 with positive and 10 with negative ^13C-urea breath test (UBT) results, will undergo the same investigational procedure, consisting of 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.
| Arm | Type | Receives |
|---|---|---|
| HP String Test With Rapid Antigen Assay | Experimental | Diagnostic Test: HP String Test With Rapid Antigen Assay |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-75 years.
- Completed a 13C-urea breath test (UBT) within 28 days prior to enrollment, with documented test results.
- Able to understand the study procedures and willing to provide written informed consent.
Key exclusion criteria (2 listed)
- History of dysphagia, esophageal stricture, or gastrointestinal obstruction.
- Use of antibiotics, bismuth-containing agents, or proton pump inhibitors (PPIs) within 4 weeks prior to enrollment, as these medications may affect H. pylori antigen detection.
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 |
|---|---|---|
| HP String Test With Rapid Antigen AssayGastric 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. | Diagnostic test | HP String Test With Rapid Antigen Assay |
Primary outcome
Diagnostic Sensitivity and Specificity of the HP String Test With Rapid Antigen Assay
Time frame: At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Diagnostic sensitivity and specificity of the gastric string test combined with a rapid antigen assay for detecting Helicobacter pylori infection, using the ^13C-urea breath test (UBT) as the reference standard (DOB ≥4.0 indicating a positive result and DOB <4.0 indicating a negative result).
1 secondary outcome
Correlation Between T-Line Color Intensity and ^13C-UBT DOB Values
Time frame: At the study visit (approximately 1-2 hours after initiation of the string test procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with external researchers to protect participant confidentiality and comply with institutional data protection policies. Only aggregated study results and findings published in scientific journals will be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HP String Test With Rapid Antigen Assay in people with Helicobacter Pylori, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-tse Chiu, MD (+886912410603, b95401030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity and Specificity of the HP String Test With Rapid Antigen Assay (time frame: At the study visit (approximately 1-2 hours after initiation of the string test procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.