Helicobacter pylori infection
Conditions
Interventions
Initial treatmen-Experimental group (TA1):Tegoprazan 50mg 2/day + Amoxicillin 1000mg 3/day for 14 days
Initial treatment-Control group (VA1):Vonoprazan 20mg 2/day + Amoxicillin 1000mg 3/day for 14 days
Remedial treatment-Control group (VA2):Vonoprazan 20mg 2/day + Amoxicillin 1000mg 3/day for 14 days
Remedial treatment-Experimental group (TA2):Tegoprazan 50mg 3/day + Amoxicillin 1000mg 3/day for 14 days
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Initial patient inclusion criteria 1.18~65 years old, gender unlimited; 2. It was diagnosed with H. pylori infection by urea breath test; 3. There are indications of H. pylori eradication without countervailing factors; 4. did not receive H. pylori eradication therapy; 5. No antibiotics, bismuth and antibacterial active Chinese medicine were taken 4 weeks before treatment; No P-CAB, PPI, H2 receptor antagonists or non-steroidal anti-inflammatory drugs were taken in the first 2 weeks. 6. Informed and consented to participate in this study. Remedial patient inclusion criteria 1. 18~65 years old, gender unlimited; 2. The following two tests were diagnosed as H. pylori infection: urea breath test, monoclonal fecal antigen test; 3. After one failure of anti-H. pylori treatment, 6-24 months from the last treatment; 4. In addition to dyspepsia and chronic gastritis, no other digestive diseases and surgical history; 5. no severe diarrhea (watery stool more than 3 times a day and lasting for more than 3 days), constipation (less than 2 times a week with difficulty defecating), blood in the stool and other symptoms in the past 1 month; 6. Informed and consented to participate in this study
Exclusion criteria
Exclusion criteria: Initial patient exclusion criteria 1. There are important basic diseases and digestive system surgery history, such as serious heart, liver, lung, renal insufficiency, low immunity; 2. History of allergy to penicillin or regimen related drugs; 3. Complicated with serious gastrointestinal diseases, such as tumors, gastrointestinal bleeding, Zhuo - Ai syndrome, etc.; 4. in the pregnancy or lactation period; 5. participating in other clinical experimenters; 6. Researchers believe that it is not suitable for inclusion. Remedial patient exclusion criteria 1. Received one or more standard high-dose amoxicillin containing combination therapy; 2. Have important underlying diseases and surgical history, such as serious heart, liver, lung, renal insufficiency, low immunity; 3. The presence of penicillin or protocol related drug allergy history; 4. In the past 1 month, they have taken PPI, P-CAB, H2-receptor antagonists, antibiotics, Chinese medicines with antibacterial activity, bismuth agents, probiotics, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressants or hormones; 5. Have taken laxatives or acute gastroenteritis in the past 4 weeks; 6. During pregnancy or lactation; 7. Researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication rate;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance;Annual reinfection rate;gastric mucosal microbiota;gut microbiota; | — |
Countries
China
Contacts
Public ContactLi Peiyuan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed