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A national multicenter open randomized parallel controlled clinical study on the first treatment of Helicobacter pylori positive chronic gastritis patients with Compound Eosinophil-Lactobacillus quadruple therapy

A national multicenter open randomized parallel controlled clinical study on the first treatment of Helicobacter pylori positive chronic gastritis patients with Compound Eosinophil-Lactobacillus quadruple therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082227
Enrollment
Unknown
Registered
2024-03-25
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Helicobacter pylori positive chronic gastritis

Interventions

Test A1 group:Rabeprazole enteric-coated capsule + Amoxicillin capsule + Tetracycline tablet + Compound Eosinophil-Lactobacillus Tablets capsules were taken for 14 days
Test A2 group:Rabeprazole enteric-coated capsule + Amoxicillin capsule +Tetracycline tablet + Bismuth potassium citrate capsules + Compound Eosinophil-Lactobacillus Tablets capsules were taken for 10
Control group B:Rabeprazole enteric-coated capsule + Amoxicillin capsule +Tetracycline tablet + Bismuth potassium citrate capsules were taken for 14 days

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 65 years,no gender limit; 2.Helicobacter pylori positive chronic gastritis patients(?Helicobacter pylori positive refers to 13/14C urea breath test positive within 2 weeks before enrollment;?Chronic gastritis refers to the diagnosis of chronic non atrophic gastritis/atrophic gastritis through gastroscopy within 6 months before enrollment, and the exclusion of concurrent esophagitis, gastric or duodenal ulcers, etc) 3.Normal liver and kidney function(Note: Patients are required to provide their own blood and urine routine, liver and kidney function test results within the three months prior to enrollment, and the results must be copied upon enrollment) 4.Has not received Helicobacter pylori eradication treatment in the past; 5.Not taking any probiotic preparations within 2 weeks; 6.Not using any antibiotic preparations within 4 weeks; 7.Penicillin non allergic individuals((Note: Regarding penicillin skin test. ? Based on clinical trials, penicillin skin test should be conducted before the trial. ? For those who have used penicillin or amoxicillin before and have no adverse reactions, they are required to sign and confirm, and can operate according to the specific requirements of their respective hospitals for oral amoxicillin drugs.); 8.The subjects (including male subjects) agree to have no family planning and voluntarily take effective contraceptive measures within 3 months from the screening date until the last administration of the study drug; 9.Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment.

Exclusion criteria

Exclusion criteria: 1.Individuals with a history of penicillin allergy; 2.Previously received Helicobacter pylori eradication treatment; 3.Four weeks prior to enrollment, acid suppressants such as P-CAB, proton pump inhibitors (PPI), H2 receptor blockers (H2RA), bismuth agents, antibiotics, etc. were used; 4.Patients with impaired liver and kidney function, malignant tumors (with a history of illness or undergoing treatment), and severe chronic systemic diseases (heart, lung, liver, blood, kidney, nervous, endocrine); 5.Pregnant or lactating women; 6.Patients who are using drugs that may interact with experimental drugs such as tetracycline (such as antacids such as sodium bicarbonate; drugs containing metal ions such as calcium, magnesium, and iron; diuretics such as furosemide; anticoagulants; isotretinoin and other hepatotoxic drugs); 7.Those who have participated in other drug research within 3 months; 8.The patient is unable to express their symptoms and wishes correctly, and cannot cooperate with the experimenter; 9.Other situations that the researcher deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Symptom remission;

Countries

China

Contacts

Public ContactJianxiang Liu

Peking University First Hospital

jxiangliu@sohu.com+86 136 9100 9303

Outcome results

None listed

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