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Clinical study on the differential microbiota in the stomach of Helicobacter pylori infected individuals with different symptoms

Clinical study on the differential microbiota in the stomach of Helicobacter pylori infected individuals with different symptoms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116275
Enrollment
Unknown
Registered
2026-01-07
Start date
2024-08-22
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Gastric diseases caused by Helicobacter pylori infection

Interventions

Helicobacter pylori infection negative subjects:No
Helicobacter pylori positive and asymptomatic subjects:No
Subjects with positive Helicobacter pylori infection and symptoms of chronic superficial gastritis:No

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 18 to 60 years old (2) Diagnosed with Helicobacter pylori infection and asymptomatic or symptomatic chronic superficial gastritis; Or those who are negative for Helicobacter pylori infection and have no stomach diseases. The symptoms of chronic superficial gastritis refer to varying degrees of digestive discomfort in the subject, such as upper abdominal discomfort, dull pain after eating, accompanied by belching, nausea, acid reflux, and occasional vomiting. Asymptomatic refers to subjects who have not experienced the aforementioned digestive symptoms. Those who meet the diagnostic criteria for Hp infection in the "Guidelines for Primary Diagnosis and Treatment of Helicobacter pylori Infection (Practice Edition · 2019)", that is, those who meet one of the following three criteria, can be judged as Hp current infection: a. Positive for any one of the three tests, including rapid urease test (RUT), tissue section staining, or bacterial culture, in gastric mucosal tissue; b. 13C urease breath test (13C-UBT) or 14C-UBT shows positive for Helicobacter pylori infection. c. Fecal Hp antigen (HpSA) detection (clinically validated monoclonal antibody method) is positive; The serum Hp antibody test (a clinically validated and highly accurate reagent) is positive for individuals who have never received treatment. (3) Those who voluntarily undergo gastroscopy examination and provide gastric mucosal samples. (4) Voluntarily participate in this experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Age below 18 or above 60 years old. (2) Those currently in pregnancy, lactation, or pre pregnancy. (3) Individuals with mental illnesses, immune system disorders, cardiovascular, lung, liver, kidney diseases, malignant tumors, coagulation disorders, etc. (4) Individuals with a history of treatment for Helicobacter pylori infection. (5) Individuals who have used antibiotics, probiotics, proton pump inhibitors, H2 receptor antagonists, bismuth preparations, laxatives, antidiarrheal drugs, or certain antibacterial traditional Chinese medicines within the past 4 weeks. (6) Individuals with a history of gastrointestinal surgery. (7) Other clinical doctors believe that participants are not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
Composition of gastric antral microbiota;

Secondary

MeasureTime frame
Pathological examination of gastric antrum;Gastrointestinal Clinical Symptom Assessment Form;

Countries

China

Contacts

Public ContactXinjuan Liu

Department of Gastroenterology, Beijing Chaoyang Hospital, Capital Medical University

lxjw2012@126.com+86 136 5117 7334

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026