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A multicenter randomized controlled trial of optimised dual therapy and quadruple therapy containing metronidazole bismuth in newly treated patients with Helicobacter pylori

A multicenter randomized controlled trial of optimised dual therapy and quadruple therapy containing metronidazole bismuth in newly treated patients with Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039096
Enrollment
Unknown
Registered
2020-10-16
Start date
2020-10-28
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

Helicobacter pylori infection

Interventions

Sponsors

Department of Gastroenterology,Army Medical Center of PLA (Daping Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years old, male or female. 2. Patients with chronic gastritis diagnosed by gastroscopy, with or without healed gastric ulcer or duodenal bulb ulcer. 3. Patients with positive rapid urease test and urea breath test. 4. Patients who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. have taken PPIs, H2RAS, antibiotics,bismuth or probiotics in the last 4 weeks; 2. patients with pregnancy,nursing or fertility programs during the study period; 3. taking NSAIDs,adrenal cortical hormone,anticoagulants or alcohol; 4. history of hypersensitivity to study drugs; 5. serious concomitant diseases:heart,lung,liver,kidney,metabolic disease,mental illness or malignant tumors; 6. previous gastric or esophagus surgeries; 7. have participated in other drug research in the last 3 months; 8. difficult to complete follow-up or have other factors that may affect compliance.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Compliance;The relief of digestive tract symptoms;the relief of anxiety / depression;cost-efficacy ratio;Adverse events;

Countries

China

Contacts

Public ContactChunhui LAN

Department of Gastroenterology, PLA Army characteristic medical center

lanchunhui@tmmu.edu.cn+86 23-68757616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026