Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication
Brief summary
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
Interventions
DRUGJWC containing quadruple therapy
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* IgA nephropathy diagnosed by renal biopsy; * Current Helicobacter pylori infection; * Age 18-65.
Exclusion criteria
* ①eGFR\<90ml/（min·1.73m2）- * History of Helicobacter pylori treatment * Present taking hormones or immunosuppressants * Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa * Allergy history to medicines used in the study * History of gastric surgery * Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment * Combined with other primary or secondary nephropathy except for IgAN * Combined with acute renal injury * Female patients with pregnancy, lactation and planned pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradicaion rate | The forth week after the treatment. | The Helicobacter pylori infection status was measured by 13-carbon breath test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood urea nitrogen level | Baseline, the third and sixth month after the treatment, respectively. | The change of average blood urea nitrogen level between two groups. |
| eGFR | Baseline, the third and sixth month after the treatment, respectively. | The change of average eGFR level between two groups. |
| 24hrs urine protein level | Baseline, the third and sixth month after the treatment, respectively. | The change of average24hrs urine protein level between two groups. |
| Blood creatinine level | Baseline, the third and sixth month after the treatment, respectively. | The change of average blood creatinine level between two groups. |
| IgA level | Baseline, the third and sixth month after the treatment, respectively. | The change of average IgA level level between two groups. |
| IgA1 level | Baseline, the third and sixth month after the treatment, respectively. | The change of average IgA1 level between two groups. |
| Gd-IgA1 level | Baseline, the third and sixth month after the treatment, respectively. | The change of average Gd-IgA1 level level between two groups. |
| Blood presure | Baseline, the third and sixth month after the treatment, respectively. | The change of average blood presure level between two groups. |
Countries
China
Outcome results
None listed