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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

2,242

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2024

Geographic Reach

1 country

26 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

March 11, 2024

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed

Last Updated

December 30, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

May 14, 2024

Last Update Submit

December 26, 2024

Conditions

Helicobacter Pylori Infection Dyspepsia

Keywords

Helicobacter Pylori InfectionDyspepsia

Outcome Measures

Primary Outcomes (2)

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
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

Study Arms (1)

Dyspepsia with Helicobacter pylori infection

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

Interventions

Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）OTHER

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.

Dyspepsia with Helicobacter pylori infection

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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.

You may qualify if:

Male or female patients aged 18-80 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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai Jiao Tong University School of Medicinelead

Study Sites (26)

Chongqing Daping Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The Ninth People's Hospital of Chongqing

Chongqing, Chongqing Municipality, China

RECRUITING

The People's Hospital of Kaizhou District, CQ

Chongqing, Chongqing Municipality, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

The People's Hospital of Wuwei

Wuwei, Gansu, China

RECRUITING

The First People's Hospital of Qinzhou

Qinzhou, Guangxi, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

Yongcheng People's Hospital of Henan Province

Shangqiu, Henan, China

RECRUITING

Xuchang Central Hospital

Xuchang, Henan, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

Dalian Friendship Hospital

Dalian, Liaoning, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Ruijin Hospital Luwan Branch