Multicenter NHPH Eradication Study

JRCT ID: jRCTs031240066

Registered date:08/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Helocobactor Pylori Helicobactor infection gastiritis
• Date of first enrollment: 08/05/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Administration of bactericidal drugs

Outcome(s)

• Primary Outcome: Sterilization availability

Secondary Outcome

Determination of effective eradication regimen based on drug susceptibility results and eradication success/failure
Evaluate the efficacy of eradication in NHPH-infected gastritis.
The study will also explore the possibility of using the specimens obtained in this study to determine what kind of changes will occur in the patients.

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients (whether male or female) 18 years of age or older
2) Written consent to participate in the study is obtained from the patient or a surrogate
3) Patients with NHPH infection or very strong suspicion of NHPH infection
Patients are considered to be infected if they test positive for two or more of the following: gastric fluid PCR, culture, microscopy, and positive serum antibodies.
4) Patients who are H. pylori negative or after successful H. pylori eradication treatment
5) Inpatients, whether inpatient or outpatient

Exclude criteria

1) Patients whose consent could not be obtained
2) Patients with uncontrolled complications
Patients with advanced cancer
Patients with acute or unstable underlying disease
3) Pregnant or lactating women
4) Patients who are taking drugs that are predicted to have a high incidence of drug interactions when taken orally.
5) Patients with a history of allergy to medications used for oral administration
6) Patients who are deemed inappropriate by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Suzuki HIdekazu
• Secondary Sponsor: Rimbara Emiko
• Source(s) of Monetary Support: AMED,The japanese society of Helicobactor Reserch