Helicobacter Pylori InfectionNCT06422052
Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
An observational study of Helicobacter Pylori Infection and Dyspepsia, run by Shanghai Jiao Tong University School of Medicine at 26 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia
- What is being tested?
- Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）
- How many people
- 2,242 participants
- Where
- 26 sitesChina
- Study dates
- 11 Mar 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
China26 sites, 26 recruiting
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Qiang Liu, +86 15174918099
- Recruiting
West China Fourth Hospital, Sichuan University
Chengdu, Sichuan
Yan Ou, +8615008228212
- Recruiting
Chongqing Daping Hospital
Chongqing, Chongqing Municipality
Chunhui Lan, +86 13896067955
- Recruiting
The Ninth People's Hospital of Chongqing
Chongqing, Chongqing Municipality
Xiaoying Yuan, +86 13983850146
- Recruiting
The People's Hospital of Kaizhou District, CQ
Chongqing, Chongqing Municipality
Qiang Wu, +8618223960853
- Recruiting
Dalian Friendship Hospital
Dalian, Liaoning
Fucheng Wang, +86 15542626166
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Lina Liang, +8618098875591
- Recruiting
The Second People's Hospital of Kashgar, Xinjiang
Kashgar, Xinjiang
Jilin Wang, +8613761853016, wangjilin811123@163.com
- Recruiting
Second People's Hospital of Jinning District, Kunming City
Kunming, Yunnan
Zhouhua Li, +8613769108442
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yanli Bai, +86 13653794460
- Recruiting
Ningbo Hangzhou Bay Hospital
Ningbo, Zhejiang
Shuliang Zhao, +057458993397
- Recruiting
The People's Hospital of Shengzhou
Ningbo, Zhejiang
Shan Yu, +8613456521442
- Recruiting
The First People's Hospital of Qinzhou
Qinzhou, Guangxi
Meimei Zeng, +8615107774335
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Hong Lu, MD, +8613611958022, hlu@sjtu.edu.cn
- Recruiting
Ruijin Hospital Luwan Branch
Shanghai, Shanghai Municipality
Xiong Zheng, +86 18116292085
- Recruiting
Shanghai Construction Group Hospital
Shanghai, Shanghai Municipality
Qi Liao, +8613512128067
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Qinjuan Sun, +86 13681667917
- Recruiting
Shanghai Putuo Liqun Hospital
Shanghai, Shanghai Municipality
Lamei Teng, +86 13817591903
- Recruiting
Shanghai Songjiang Central Hospital
Shanghai, Shanghai Municipality
Jing Wang, +86 18918289144
- Recruiting
Yongcheng People's Hospital of Henan Province
Shangqiu, Henan
Hongdan Ma, +86 13781408747
- Recruiting
Shengzhou People's Hospital
Shaoxing, Zhejiang
Shan Yu, +86 13456521442
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjing, Tianjing
Lin Yan, +86 18222835795
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jing Li, +86 18827603030
- Recruiting
The People's Hospital of Wuwei
Wuwei, Gansu
Xiaoyun Ma, +8613639359150
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Jinyan Zhang, +8615160042319
- Recruiting
Xuchang Central Hospital
Xuchang, Henan
Shilei Song, +86 13837421261
About this study
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
- Helicobacter Pylori Infection, Dyspepsia
- Being tested
- Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）
- Keywords
- Helicobacter Pylori Infection, Dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）Other
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Dyspepsia with Helicobacter pylori infection | Not described Receives: Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD） |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of dyspepsia in patients with Helicobacter pylori infection
Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start11 Mar 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422052
- Sponsor's protocol ID
- rjhy20240504
- Status last verified
- Nov 2024
- First submitted
- 14 May 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
- ClinicalTrials.gov ID
- NCT06422052
- Acronym / sponsor ID
- rjhy20240504
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Keywords
- Helicobacter Pylori Infection, Dyspepsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,242 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyspepsia with Helicobacter pylori infection | – | Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Dyspepsia with Helicobacter pylori infection |
Primary outcome
the incidence of dyspepsia in patients with Helicobacter pylori infection
Time frame: Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
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
The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Dyspepsia, run by Shanghai Jiao Tong University School of Medicine at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Lu, MD (+8613611958022, hlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.