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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06422052
Other study ID # rjhy20240504
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 11, 2024
Est. completion date May 31, 2025

Study information

Verified date May 2024
Source Shanghai Jiao Tong University School of Medicine
Contact Hong Lu, MD
Phone +8613611958022
Email hlu@sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2242
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Baotou Central Hospital Baotou Inner Mongolia
China West China Fourth Hospital, Sichuan University Chengdu Sichuan
China The People's Hospital of Kaizhou District, CQ Chongqing Chongqing
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China The Second People's Hospital of Kashgar, Xinjiang Kashgar Xinjiang
China Second People's Hospital of Jinning District, Kunming City Kunming Yunnan
China Ningbo Hangzhou Bay Hospital Ningbo Zhejiang
China The People's Hospital of Shengzhou Ningbo Zhejiang
China The First People's Hospital of Qinzhou Qinzhou Guangxi
China Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai
China Shanghai Construction Group Hospital Shanghai Shanghai
China The People's Hospital of Wuwei Wuwei Gansu
China The First Affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of dyspepsia in patients with Helicobacter pylori infection Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Primary Relief of Helicobacter pylori related dyspepsia The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients 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
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