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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06422052
Enrollment
2242
Registered
2024-05-20
Start date
2024-03-11
Completion date
2025-05-31
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection, Dyspepsia

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.

Interventions

OTHEREpidemiological 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.

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

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.

Design outcomes

Primary

MeasureTime frameDescription
the incidence of dyspepsia in patients with Helicobacter pylori infectionTime 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom DiaryProportion of patients with Helicobacter pylori infection with dyspeptic symptoms
Relief of Helicobacter pylori related dyspepsiaPatients 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 symptomsThe Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients

Countries

China

Contacts

Primary ContactHong Lu, MD
hlu@sjtu.edu.cn+8613611958022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026