Helicobacter pylori Infections and Infestations Refractory infection of Helicobacter pylori
Conditions
Interventions
Participants are randomly allocated to one of three options of therapy:
1. Rabeprazole 20 mg Bid and Bismuth potassium citrate 220mg Bid and amoxicillin 1g Bid and furazolidone 0.1g Bi
Sponsors
China Health Promotion Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 without gender limitation. 2. Meet the refractory Helicobacter pylori infection: 2.1. Referred after three or more than three standard therapy (according to consensus for 10-14 days, at least two times of standard quadruple therapy, at least one time for 14 days) failures in three years. 2.2. Received upper endoscopy and suitable for eradication of Helicobacter pylori. 3. Diagnosed with Helicobacter pylori infection by rapid urease test or 13C-urea breath test results. 4. Proven endoscopic gastritis (including atrophic gastritis and non-atrophic gastritis) or ulcers. 5. Participants without prior penicillin treatment need to demonstrate negative reaction to penicillin skin test. 6. No dyspepsia syndromes of epigastric discomfort, epigastric pain, acid regurgitation, heartburn, and so on, but meet indication of Helicobacter pylori eradication. 7. Accept the medications treatment voluntarily and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of stomach operation: partial gastrectomy, stomach plasty, vagotomy (but patients who had simple repair of gastroduodenal ulcer perforation or hemostatic suture of gastroduodenal ulcer were accepted) 2. Pregnancy or lactation, or childbearing age women without reliable contraception (e.g.,oophorectomy, hysterectomy, at least 6 months of tubal ligation, oral contraceptives, barrier method of contraception) 3. Cannot avoid alcohol during the experiment 4 Patients who concomitant with liver disease, kidney disease, cardiovascular disease, brain disease, pulmonary disease, endocrine system diseases, hematopoietic system disease, and other serious primary diseases which is not effectively controlled 5. Severe hepatic and renal insufficiency( transaminase is more than 1.5 times of the normal limit, or serum creatinine more than the upper limit of normal )or liver disease, anemia (hemoglobin three timesper week) or clinical trial other drugs within 30 days 8 . Taking anticoagulant therapy or non-steroidal anti-inflammatory drugs (NSAIDs) 9. Swallowing difficulties 10. Used anti-ulcer drugs, including H2-receptor blocking agent, sucralfate, misoprostol or proton pump inhibitor (PPI) within two weeks 11. Zollinger-Ellison syndrome 12. Malignant tumor 13. Included in another clinical trial within 3 months 14. Inappropriate according to the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination rate of Helicobacter pylori is measured using 13C-urea breath test at 56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms are measured using Scale of gastrointestinal symptoms at baseline, 14 days, 28 days and 56 days | — |
Countries
China
Contacts
Public ContactFulian;Shengsheng Hu;Zhang
;
Outcome results
None listed