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Clinical trial on efficacy and endoscopic pathological changes in Patients with atrophic gastritis of individualized eradication of Helicobacter pylori

Clinical trial on efficacy and endoscopic pathological changes in Patients with atrophic gastritis of individualized eradication of Helicobacter pylori

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070199
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-05-29

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

test team:H. pylori eradication according to drug resistance cause detection
control group Empirical :Empirical eradication of Helicobacter pylori

Sponsors

Civil Aviation General Hospital, Chaoyang, Beijing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Select 18-75 years old (including both ends), gender is not limited; 2) Meet the diagnostic conditions of chronic atrophic gastritis in China Consensus Opinions on Chronic Gastritis, and have positive Hp by 14C or 13C breath test; 3), the primary eradication of Helicobacter pylori; 4), with symptoms of indigestion (such as: upper abdominal pain, acid reflux, heartburn, upper abdominal distension, nausea); 5) Positive PCR test of Helicobacter pylori in the gastric mucosa; 6)

Exclusion criteria

Exclusion criteria: 1) Those who have used proton pump inhibitors or H2 receptor antagonists, antibiotics, bismuth agents, or gastric mucosal protectors within 4 weeks before screening; 2) Repeated use (use for 5 times or more within 1 year) or long-term use (continuous use for 10 weeks or more); 3) Those who are allergic to any component of the test-related drugs (bismuth agent, esiprazole, antibiotics [penicillin (amoxicillin, etc.), macrolides (clarithromycin, etc.), 4) Patients with malignant tumors or a history of esophageal and gastrointestinal surgery; 5) Patients with pyloric obstruction, gastric perforation, esophageal erosion and ulcer, esophagitis and Zhuo-Ai syndrome; 6) Patients with acute upper gastrointestinal bleeding within 1 week before screening 7) To take drugs or non-steroidal anti-inflammatory drugs that affect the anticoagulant system, coagulation system and fibrinolytic system during the test; 8) Combined with other serious cardiac, liver and renal insufficiency (ALT, AST> 1.5 times the upper limit of normal value or the upper limit of Cr> normal value), anemia (Hb <90g / L) and other serious hematopoietic and coagulation system diseases failed to be effectively controlled; 9) Pregnant or lactating women, or subjects with a positive pregnancy examination, or a birth plan within 6 months of the screening examination; 10) Have a history of drug or alcohol abuse within 1 year prior to screening, or do not agree to comply with the provisions of the trial (including alcohol prohibition) during the study; 11) The investigator is not suitable to participate in clinical trials

Design outcomes

Primary

MeasureTime frame
The H. pylori eradication rate;

Secondary

MeasureTime frame
Pathological changes in atrophic gastritis;Adverse reaction rate;

Countries

China

Contacts

Public ContactJianping Cheng

Civil Aviation General Hospital, Chaoyang, Beijing

cjpczy2004@163.com15811282039

Outcome results

None listed

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