A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Other: Remedial treatment within 3 months; Other: Remedial treatment within 3 to 6 months; Other: Remedial treatment within 6 to 12 months; Other: Remedial treatment after 12 months

Detailed Description

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

• Study Type: Observational
• Enrollment (Anticipated): 660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-70 with previous Helicobacter pylori eradication failure.

Description

Inclusion Criteria:

• Patients aged 18-70 with H. pylori infection.
• Patients with previous Helicobacter pylori eradication.

Exclusion Criteria:

• Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks.
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
• Patients with known or suspected allergy to study medications.
• Currently pregnant or lactating.
• Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; Within 3 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.	Other: Remedial treatment within 3 months; Remedial therapy was performed within 3 months
group B; Within 3 to 6 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.	Other: Remedial treatment within 3 to 6 months; Remedial therapy was performed within 3 to 6 months
group C; Within 6 to 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.	Other: Remedial treatment within 6 to 12 months; Remedial therapy was performed within 6 to 12 months
group D; After 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.	Other: Remedial treatment after 12 months; Remedial therapy was performed after 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The most suitable re-eradication time	The most suitable re-eradication time#The unit is month# will be assessed by paired comparison method .	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rates in three groups	Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups	12 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): August 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (ACTUAL): August 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022-SDU-QILU-G808

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No