## Protocol Section
### Identification Module
**NCT ID:** NCT06412588

**Brief Title:** Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

**Official Title:** Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study

#### Organization Study ID Info
**ID:** KY20240123-18
#### Organization
**Class:** OTHER
**Full Name:** Nanjing First Hospital, Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanjing First Hospital, Nanjing Medical University

#### Responsible Party

**Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University

**Investigator Full Name:** Zhenyu Zhang

**Investigator Title:** Director of Gastroenterology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

**Detailed Description:** It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

### Conditions Module

**Conditions:**

- Helicobacter Pylori Infection

**Keywords:**

- Helicobacter Pylori Infection

- Dual therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 810

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days

**Intervention Names:**

- Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

**Label:** Group A Bismuth quadruple

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days

**Intervention Names:**

- Drug: Vonoprazan+Amoxicillin

**Label:** Group B Amoxicillin Dual therapy

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days

**Intervention Names:**

- Drug: Vonoprazan+doxycycline

**Label:** Group C doxycycline Dual therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A Bismuth quadruple

**Description:** Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.

**Name:** Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

**Other Names:**

- Doxycycline-based Bismuth Quadruple Therapy

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group B Amoxicillin Dual therapy

**Description:** Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.

**Name:** Vonoprazan+Amoxicillin

**Other Names:**

- Vonoprazan+Amoxicillin Dual therapy

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Group C doxycycline Dual therapy

**Description:** Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

**Name:** Vonoprazan+doxycycline

**Other Names:**

- Vonoprazan+doxycycline Dual therapy

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Adverse drug reactions

**Measure:** Security observations

**Time Frame:** Within 3 days after the end of treatment

#### Primary Outcomes

**Description:** The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT

**Measure:** HP eradication rate

**Time Frame:** 4-6 weeks after the end of the last dose

#### Secondary Outcomes

**Description:** Rate of drug consumption during the treatment period of the subjects

**Measure:** Patient compliance

**Time Frame:** Within 3 days after the end of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age 18-65 years old;
2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
4. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
2. Patients with confirmed active peptic ulcer;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Alcoholism
9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhangzhenyu808@126.com

**Name:** Zhenyu Zhang

**Phone:** 18951670222

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18886

- Name: Helicobacter Infections

- Relevance: HIGH

- As Found: Helicobacter Pylori Infection

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000016481

- Term: Helicobacter Infections

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000962

- Term: Antimalarials

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000000863

- Term: Antacids

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005765

- Term: Gastrointestinal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M3995

- Name: Amoxicillin

- Relevance: HIGH

- As Found: Colorectal

- ID: M7493

- Name: Doxycycline

- Relevance: HIGH

- As Found: Open-Label Study

- ID: M5011

- Name: Bismuth

- Relevance: HIGH

- As Found: Initially

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4280

- Name: Antimalarials

- Relevance: LOW

- As Found: Unknown

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000658

- Term: Amoxicillin

- ID: D000004318

- Term: Doxycycline

- ID: D000001729

- Term: Bismuth

### Misc Info Module

- Version Holder: 2024-05-31
