Evaluation and comparison of positive and negative rates of C13 urea breath test in patients with different degrees of chronic atrophic gastritis infected with Helicobacter pylori

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100048683

Enrollment

Unknown

Registered

2021-07-12

Start date

2021-07-19

Completion date

Unknown

Last updated

2022-03-21

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

Conditions

Helicobacter pylori infection in chronic atrophic gastritis

Interventions

One-armed test group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male or female aged 18 years or above; 2.Be able to read and understand and sign the informed consent; 3.Patients who need to take biopsy and undergo C13 urea breath test for gastroscopy.

Exclusion criteria

Exclusion criteria: 1.Subjects meet the contraindications for gastroscopy; 2.Patients with contraindicated biopsy; 3.Patients with gastric cancer, gastroduodenal ulcer and cardiovascular and cerebrovascular diseases or blood diseases; 4.Have used antibiotic, bismuth preparation, proton pump inhibitor and other HP-sensitive drugs within the last 1 month; 5.A history of upper gastrointestinal bleeding in the past week (acute upper gastrointestinal bleeding may inhibit Hp and may cause false negative test); 6.Patients diagnosed by gastroscopy with bile reflux (to avoid false positive results of HP); 7.Pregnant women; 8.A history of partial gastrectomy; 9.High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Positive rate and negative rate of C13 urea breath test;In the follow-up patients, the positive rate of C13 urea breath test was observed to change with the severity of atrophic gastritis over time;	—

Secondary

Measure	Time frame
Effect of targeted biopsy on pathological diagnosis of Helicobacter pylori;The relationship between positive rate of C13 breath test and bacterial load in pathological biopsy was calculated;The relationship between the positive rate of C13 breath test and the severity and extent of chronic atrophic gastritis was calculated;Determine the degree and range of atrophy under magnifying staining endoscope;Analyze the correlation between the severity of endoscopic atrophic gastritis and pathological diagnosis;	—

Measure

Time frame

Effect of targeted biopsy on pathological diagnosis of Helicobacter pylori;The relationship between positive rate of C13 breath test and bacterial load in pathological biopsy was calculated;The relationship between the positive rate of C13 breath test and the severity and extent of chronic atrophic gastritis was calculated;Determine the degree and range of atrophy under magnifying staining endoscope;Analyze the correlation between the severity of endoscopic atrophic gastritis and pathological diagnosis;

—

Countries

China

Contacts

Public ContactAn Ping

Renmin Hospital of Wuhan University

anping_05@163.com+86 18627068700

Outcome results

None listed

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