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

NCT05493644 | Unknown

• 1 other identifier: 2022-SDU-QILU-G808
• Study Type: observational
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Eradication rates in three groups

  12 months

Study Arms (4)

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

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

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

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

Interventions

Remedial treatment within 3 months OTHER

Remedial therapy was performed within 3 months

group A

Remedial treatment within 3 to 6 months OTHER

Remedial therapy was performed within 3 to 6 months

group B

Remedial treatment within 6 to 12 months OTHER

Remedial therapy was performed within 6 to 12 months

group C

Remedial treatment after 12 months OTHER

Remedial therapy was performed after 12 months

group D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of gastroenterology department of Qilu hospital

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08