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

Helicobacter Pylori Infection Clinical Trial

Official title:

The Effect of Different Time Intervals on Rescue Treatment of Helicobacter Pylori Infection: a Prospective, Multicenter Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05620602
• Other study ID #: 2022-SDU-QILU-G007
• Status: Not yet recruiting
• Start date: November 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 628
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Other:
• Remedial treatment within 3 months
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 to 6 months
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 6 to 12 months
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 after 12 months
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.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (6)

Lead Sponsor	Collaborator
Shandong University	Peking University Care Luzhong Hospital, Taierzhuang District People's Hospital, Yuncheng Hospital of Traditional Chinese Medicine, Zhengzhou Central Hospital, Zibo Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (15)

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type?Rate and severtiry of adverse reactions	Type?Rate and severtiry of adverse reactions	Immediately after the procedure
Secondary	Patient compliance	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.	Immediately after the procedure