Overview

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

Status:
Recruiting

Trial end date:
2024-06-15

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shandong University

Collaborators:

Peking University Care Luzhong Hospital
People's Hospital of Zhengzhou University
Taierzhuang District People's Hospital
Yuncheng County Hospital of Traditional Chinese Medicine
Zibo Central Hospital

Treatments:

Amoxicillin
Bismuth
Esomeprazole
Tetracycline

Criteria

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