An observational study in Helicobacter Pylori Infection and Dyspepsia, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 26 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Shanghai Jiao Tong University School of Medicine · Observational
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 2,242 is above the median of 200 across 62 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
the incidence of dyspepsia in patients with Helicobacter pylori infection
Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
Time frame: 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
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
Plan to share: No
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