Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
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.
연구 개요
상세 설명
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, prospective, single-group pilot diagnostic accuracy study conducted at Fu Jen Catholic University Hospital, Taiwan.
An enriched enrollment strategy will be adopted to include 30 participants with positive UBT results and 10 participants with negative UBT results. All participants will undergo the same investigational procedure, and their previously obtained ^13C-UBT results will serve as the reference standard for diagnostic comparison.
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 this procedure will be used exclusively for research purposes and will not guide clinical diagnosis or treatment decisions.
Study Procedures
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 and 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 approximately 3-5 minutes.
In addition to qualitative interpretation, 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.
Safety Monitoring
Participant discomfort during capsule swallowing, gastric retention, and string retrieval will be evaluated using a Visual Analog Scale (VAS).
Potential procedure-related adverse events, including nausea, gagging, throat discomfort, mucosal irritation or injury, bleeding, and difficulty retrieving the string, will be monitored and documented. Clinically significant adverse events will be managed according to institutional clinical practice, and serious adverse events will be reported to the Institutional Review Board in accordance with applicable regulations.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yu-tse Chiu, MD
- 전화번호: +886912410603
- 이메일: b95401030@gmail.com
연구 장소
-
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Taiwan
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New Taipei City, Taiwan, 대만, 24352
- Fu Jen Catholic University Hospital
-
연락하다:
- Yu-tse Chiu, MD
- 전화번호: +886912410603
- 이메일: b95401030@gmail.com
-
수석 연구원:
- Yu-tse Chiu, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic Sensitivity and Specificity of the HP String Test With Rapid Antigen Assay
기간: 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). |
At the study visit (approximately 1-2 hours after initiation of the string test procedure)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation Between T-Line Color Intensity and ^13C-UBT DOB Values
기간: At the study visit (approximately 1-2 hours after initiation of the string test procedure)
|
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. |
At the study visit (approximately 1-2 hours after initiation of the string test procedure)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FJUH115665
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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미국 FDA 규제 기기 제품 연구
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