The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Other: Remedial treatment within 3 to 6 monthsOther: Remedial treatment within 3 monthsOther: Remedial treatment after 12 monthsOther: Remedial treatment within 6 to 12 months
- Registration Number
- NCT05620602
- Lead Sponsor
- Shandong University
- 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.
- Detailed 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 & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 628
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Remedial treatment within 3 to 6 months Remedial treatment within 3 to 6 months - Remedial treatment within 3 months Remedial treatment within 3 months - Remedial treatment after 12 months Remedial treatment after 12 months - Remedial treatment within 6 to 12 months Remedial treatment within 6 to 12 months -
- Primary Outcome Measures
Name Time Method Eradication rate at different time intervals immediately after the procedure 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.
- Secondary Outcome Measures
Name Time Method Patient compliance Immediately after the procedure Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Type、Rate and severtiry of adverse reactions Immediately after the procedure Type、Rate and severtiry of adverse reactions
Trial Locations
- Locations (1)
Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China