The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

NCT05620602 | Unknown

• 1 other identifier: 2022-SDU-QILU-G007
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate at different time intervals

  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 two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

  immediately after the procedure

Secondary Outcomes (2)

• Type、Rate and severtiry of adverse reactions

  Immediately after the procedure

• Patient compliance

  Immediately after the procedure

Study Arms (4)

Remedial treatment within 3 months

Other: Remedial treatment within 3 months

Remedial treatment within 3 to 6 months

Other: Remedial treatment within 3 to 6 months

Remedial treatment within 6 to 12 months

Other: Remedial treatment within 6 to 12 months

Remedial treatment after 12 months

Other: Remedial treatment after 12 months

Interventions

Remedial treatment within 3 months OTHER

The interval between the time of this treatment and the last day of the last therapy is within 3 months.Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

Remedial treatment within 3 months

Remedial treatment within 3 to 6 months OTHER

The interval between the time of this treatment and the last day of the last therapy is 3-6 months. Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

Remedial treatment within 3 to 6 months

Remedial treatment within 6 to 12 months OTHER

The interval between the time of this treatment and the last day of the last therapy is 6-12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

Remedial treatment within 6 to 12 months

Remedial treatment after 12 months OTHER

The interval between the time of this treatment and the last day of the last therapy is more than 12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

Remedial treatment after 12 months

Eligibility Criteria

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

Study Population

The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.

You may qualify if:

• Patients aged 18-70.
• Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
• Patients who have previously received helicobacter pylori eradication therapy and failed.

You may not qualify if:

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
• Patients with active gastrointestinal bleeding.
• Patients with a history of upper gastrointestinal surgery.
• Patients allergic to treatment drugs.
• Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
• Patients who are unwilling or incapable to provide informed consents.

Sponsors & Collaborators

• Shandong University: lead
• Peking University Care Luzhong Hospital: collaborator
• Yuncheng Traditional Chinese Medicine Hospital: collaborator
• Taierzhuang District People's Hospital: collaborator
• Zhengzhou Central Hospital: collaborator
• Zibo Central Hospital: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (15)

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: November 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)