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The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin combined with vonoprazan | Active Comparator | The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days |
|
| Probiotics combined with vonoprazan and amoxicillin | Experimental | The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Potassium-competitive acid blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of the gut microbiota composition | Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages. | 12mouth |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. | four to six weeks after completion of the medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Zhang | Contact | +86 025-87726248 | zzy6565@sina.com | |
| Yunfan Dong | Contact | +86 18795993220 | dyf967878@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Zhang | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | Antibiotic for H. pylori eradication |
|
| probiotics | Drug | Medilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China |
|
| Adverse event |
adverse events are recorded by the patient |
| one week after completion of the medication |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |