## Protocol Section
### Identification Module
**NCT ID:** NCT06422052

**Brief Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms

**Official Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms

#### Organization Study ID Info
**ID:** rjhy20240504
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Jiao Tong University School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Jiao Tong University School of Medicine

#### Responsible Party

**Investigator Affiliation:** Shanghai Jiao Tong University School of Medicine

**Investigator Full Name:** Hong Lu, MD

**Investigator Title:** Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms.

### Conditions Module

**Conditions:**

- Helicobacter Pylori Infection

- Dyspepsia

**Keywords:**

- Helicobacter Pylori Infection

- Dyspepsia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2242

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）

**Label:** Dyspepsia with Helicobacter pylori infection

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dyspepsia with Helicobacter pylori infection

**Description:** H. pylori infection was confirmed by 13C/ 14C-breath test and/or rapid urease test under endoscopy and histopathological examination. Epidemiological questionnaire and Functional Dyspepsia Symptom Diary (FDSD) were used to investigate basic information and assess dyspeptic symptoms. Patients with dyspepsia who successfully eradicated Helicobacter pylori infection will be followed up for dyspeptic symptoms after 2 months and 6 months to evaluate the relief of dyspeptic symptoms.

**Name:** Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms

**Measure:** the incidence of dyspepsia in patients with Helicobacter pylori infection

**Time Frame:** Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary

**Description:** The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients

**Measure:** Relief of Helicobacter pylori related dyspepsia

**Time Frame:** Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female patients aged 15-80 years
* H. pylori infection diagnosed by 13C/ 14C-UBT (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive)
* Treatment-naive patients with Helicobacter pylori
* Ability and willingness to participate in the study and to sign and give informed consent

Exclusion Criteria:

* Under 18 or over 80 years old
* Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc.
* Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms
* Pregnant and lactating women
* History of cancer
* History of subtotal gastrectomy
* Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study population targets male and female patients aged 15-80 who have not previously been treated for Helicobacter pylori and have been diagnosed via 13C/14C urea breath test or gastroscopy. Participants must be willing and able to give informed consent. Exclusions include individuals under 18 or over 80, those with organic digestive diseases, pregnant or nursing women, those with a history of cancer or partial gastrectomy, and individuals with severe organ dysfunction or congenital diseases. Also excluded are those with symptoms like melena, hematemesis, anemia, or cachexia.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hlu@sjtu.edu.cn

**Name:** Hong Lu, MD

**Phone:** +8613611958022

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chongqing

**Contacts:**

***Contact 1:***

- **Name:** Qiang Wu

- **Phone:** +8618223960853

- **Role:** CONTACT

**Country:** China

**Facility:** The People's Hospital of Kaizhou District, CQ

**State:** Chongqing

**Status:** RECRUITING

**Location 2:**

**City:** Xiamen

**Contacts:**

***Contact 1:***

- **Name:** Jinyan Zhang

- **Phone:** +8615160042319

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Xiamen University

**State:** Fujian

**Status:** RECRUITING

**Location 3:**

**City:** Wuwei

**Contacts:**

***Contact 1:***

- **Name:** Xiaoyun Ma

- **Phone:** +8613639359150

- **Role:** CONTACT

**Country:** China

**Facility:** The People's Hospital of Wuwei

**State:** Gansu

**Status:** RECRUITING

**Location 4:**

**City:** Qinzhou

**Contacts:**

***Contact 1:***

- **Name:** Meimei Zeng

- **Phone:** +8615107774335

- **Role:** CONTACT

**Country:** China

**Facility:** The First People's Hospital of Qinzhou

**State:** Guangxi

**Status:** RECRUITING

**Location 5:**

**City:** Baotou

**Contacts:**

***Contact 1:***

- **Name:** Qiang Liu

- **Phone:** +86 15174918099

- **Role:** CONTACT

**Country:** China

**Facility:** Baotou Central Hospital

**State:** Inner Mongolia

**Status:** RECRUITING

**Location 6:**

**City:** Dalian

**Contacts:**

***Contact 1:***

- **Name:** Lina Liang

- **Phone:** +8618098875591

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Dalian Medical University

**State:** Liaoning

**Status:** RECRUITING

**Location 7:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** hlu@sjtu.edu.cn

- **Name:** Hong Lu, MD

- **Phone:** +8613611958022

- **Role:** CONTACT

**Country:** China

**Facility:** Renji Hospital, School of Medicine, Shanghai Jiao Tong University

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200127

**Location 8:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Qi Liao

- **Phone:** +8613512128067

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai Construction Group Hospital

**State:** Shanghai

**Status:** RECRUITING

**Location 9:**

**City:** Chengdu

**Contacts:**

***Contact 1:***

- **Name:** Yan Ou

- **Phone:** +8615008228212

- **Role:** CONTACT

**Country:** China

**Facility:** West China Fourth Hospital, Sichuan University

**State:** Sichuan

**Status:** RECRUITING

**Location 10:**

**City:** Kashgar

**Contacts:**

***Contact 1:***

- **Email:** wangjilin811123@163.com

- **Name:** Jilin Wang

- **Phone:** +8613761853016

- **Role:** CONTACT

**Country:** China

**Facility:** The Second People's Hospital of Kashgar, Xinjiang

**State:** Xinjiang

**Status:** RECRUITING

**Location 11:**

**City:** Kunming

**Contacts:**

***Contact 1:***

- **Name:** Zhouhua Li

- **Phone:** +8613769108442

- **Role:** CONTACT

**Country:** China

**Facility:** Second People's Hospital of Jinning District, Kunming City

**State:** Yunnan

**Status:** RECRUITING

**Location 12:**

**City:** Ningbo

**Contacts:**

***Contact 1:***

- **Name:** Shuliang Zhao

- **Phone:** +057458993397

- **Role:** CONTACT

**Country:** China

**Facility:** Ningbo Hangzhou Bay Hospital

**State:** Zhejiang

**Status:** RECRUITING

**Location 13:**

**City:** Ningbo

**Contacts:**

***Contact 1:***

- **Name:** Shan Yu

- **Phone:** +8613456521442

- **Role:** CONTACT

**Country:** China

**Facility:** The People's Hospital of Shengzhou

**State:** Zhejiang

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### 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: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7589

- Name: Dyspepsia

- Relevance: HIGH

- As Found: Dyspepsia

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004415

- Term: Dyspepsia

### Misc Info Module

- Version Holder: 2024-05-31
