Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste.

Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste. - Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045892

Enrollment

150

Registered

2021-11-01

Start date

2019-12-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following conditions (1) Patients suspected of H. pylori infection and recommended to undergo endoscopy (2) Patients who consented to conduct a urea breath test (UBT) and submit stool (stool H. pylori antigen test) before endoscopy (3) 15 years old and over

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions (1) Patients who did not obtain sufficient samples for the study (2) Patients who have already received H. pylori eradication treatment (3) Patients with serious disabilities (4) Pregnant or potentially pregnant patients (5) Other patients who the attending physician has determined to be unable to participate in the study

Design outcomes

Primary

Measure	Time frame
For H. pylori molecular diagnostic kit using gastric wash waste, evaluation of the correlation with H. pylori conventional diagnostic method (urea breath test, stool antigen test, culture) and evaluation of the concordance with clarithromycin antibiotic susceptibility test. For H. pylori molecular diagnostic kit using stool, evaluation of the sensitivity compared with stool antigen test, and evaluation of the concordance with clarithromycin antibiotic susceptibility test.	—

Measure

Time frame

For H. pylori molecular diagnostic kit using gastric wash waste, evaluation of the correlation with H. pylori conventional diagnostic method (urea breath test, stool antigen test, culture) and evaluation of the concordance with clarithromycin antibiotic susceptibility test. For H. pylori molecular diagnostic kit using stool, evaluation of the sensitivity compared with stool antigen test, and evaluation of the concordance with clarithromycin antibiotic susceptibility test.

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Countries

Japan

Contacts

Public ContactKoichi Ebisu

MIZUHO MEDY Co., Ltd. R&D Planning Dept.

ebisu@mizuho-m.co.jp0942-85-0301

Outcome results