Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.

Phase 4

Recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Tetracycline 500mg tid; Drug: Tetracycline 500mg qid

• Registration Number: NCT05802888
• Lead Sponsor: Shandong University

Brief Summary

The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates and patient compliance of each group.

Detailed Description

The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated.

According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid

Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-09
• Study Start: 2023-03-12
• Study First Submitted QC: 2023-03-25
• Last Update Submitted: 2023-03-25
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Patients aged 18-70.
2. Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
3. Patients who have previous failed H. pylori eradication treatment, and ≤ 2 times.

Exclusion Criteria

1. 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%.
2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
3. Patients with active gastrointestinal bleeding.
4. Patients with a history of upper gastrointestinal surgery.
5. Patients allergic to treatment drugs.
6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
8. Patients who are unwilling or incapable to provide informed consents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tid group	Tetracycline 500mg tid	Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
Qid group	Tetracycline 500mg qid	Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid

Primary Outcome Measures

Name	Time	Method
Eradication rate	through study completion, an average of 1.5 years	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
Rate of adverse reactions	through study completion, an average of 1.5 years	Rate of adverse reactions
Patient compliance	through study completion, an average of 1.5 years	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.

Trial Locations

Locations (1)

Department of Gastroenterology,QiLu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China