Reserch Non-Helicobacter pylori Helicobacter infection

JRCT ID: jRCTs031200105

Registered date:02/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric MALT lymphoma, intractable peptic ulcer
• Date of first enrollment: 13/10/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): In case of confirmed H. suis infection, deworming agent is administered

Outcome(s)

• Primary Outcome: Success or failure of NHPH include H.suis sterilization and the efficacy of eradication of disease

Secondary Outcome

Identify the most recommended method of H.suis sterilization
Verification of which H.suis infection diagnostics are useful in determining the success of eradication

1. gastric MALT lymphoma patients and gastric/duodenal ulcer patients after H.pylori-negative or H.pylori eradication treatment NHPH infection rate including H.suis
2. incidence of adverse events due to NHPH eradication, including H.suis
3. evaluation of drugs for the treatment of NHPH infection, including H.suis
4. evaluation of diagnostic methods for NHPH infection, including H.suis

Key inclusion & exclusion criteria

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

Include criteria

Patients with H.pylori negative gastric MALT lymphoma who are able to observe the lesion endoscopically
Patients with H.pylori-negative or non-NSAIDs confirmed gastric or duodenal ulcer after eradication
1) Patients (both male and female) over the age of 18
2) Patients who have obtained written consent and their surrogates (if they are minors, consent is obtained from the surrogate)
3) Patients diagnosed with gastric MALT lymphoma or gastric or duodenal ulcer
4) Patients who are H.pylori negative or after successful H.pylori eradication treatment
(5) Whether inpatient or outpatient

Exclude criteria

1) Patients who could not give consent
2) Patients with poorly controlled complications
Patients with advanced stages of cancer
Patients with acute or unstable underlying disease
3) Pregnant or lactating women
4) Patients taking drugs with a high rate of drug interactions expected to occur during treatment

Related Information

• Primary Sponsor: Suzuki Hidekazu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development