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Randomized controlled trial of efficacy and safety of non-antibiotic triple therapy containing linolenic acid and Polaprezinc for the first treatment of Helicobacter pylori infection

Randomized controlled trial of efficacy and safety of non-antibiotic triple therapy containing linolenic acid and Polaprezinc for the first treatment of Helicobacter pylori infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037961
Enrollment
Unknown
Registered
2020-09-07
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Helicobacter pylori infection

Interventions

1:Bismuth - containing standard quadruple eradication
2:Linolenic acid and polyprezinc14 days
3:Linolenic acid and polyprezinc14 days

Sponsors

Jiangsu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years male and female; 2. Patients with positive C 13 breath test and confirmed HP infection; 3. Patients treated for the first time; 4. Patients with informed consent and voluntary participation.

Exclusion criteria

Exclusion criteria: 1. Patients who have used probiotics, antibiotics, bismuth containing drugs (such as bismuth potassium citrate capsules, etc.) or histamine receptor antagonists (such as famotidine, ranitidine, cimetidine, etc.) and proton pump inhibitors (such as omeprazole, lansoprazole, pantoprazole, rabeprazole, esmesomeprazole, etc.) in the past 4 weeks; 2. Patients who are allergic to the drugs used in the treatment plan: amoxicillin, clarithromycin, esomeprazole enteric coated tablets, colloidal bismuth pectin, and polyprazin; 3. Patients with acute upper gastrointestinal bleeding, early and advanced upper gastrointestinal cancer were excluded by gastroscopy; 4. Pregnant or lactating women; 5. Patients with severe primary diseases of liver, kidney, heart, brain, lung, endocrine system and hematopoietic system that can not be effectively controlled; 6. Patients with clinical significance of liver and kidney dysfunction (transaminase is more than 1.5 times of the upper limit of normal value, or serum creatinine is greater than the upper limit of normal value); 7. Patients with malignant tumor due to mental disorder who can not give full informed consent; 8. Patients who participated in other clinical trials within three months before enrollment; 9. In addition to the above, the researcher judged the patients who were not suitable to participate in the clinical trial; according to the researcher's judgment, other situations were not suitable for joining the group.

Design outcomes

Primary

MeasureTime frame
C13 breath testing;

Countries

China

Contacts

Public ContactZhang guoxin

Department of Gastroenterology, The First Affliated Hospital of Nanjing Medical University, Nanjing, China

fengye@njmu.edu.cn+86 13815897873

Outcome results

None listed

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