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A randomized, controlled clinical trial comparing the efficacy of individualized therapy versus empirical therapy for Helicobacter pylori infection

A randomized, controlled clinical trial comparing the efficacy of individualized therapy versus empirical therapy for Helicobacter pylori infection

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082653
Enrollment
Unknown
Registered
2024-04-02
Start date
2023-04-13
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Helicobacter pylori infection

Interventions

Empirical treatment group:Select any one of the seven quadruple regimens (two antibiotics+PPI+bismuth) recommended by the Fifth National Consensus on the Diagnosis and Treatment of Helicobacter pylori
14 days of treatment
Individualized treatment group:According to the drug sensitivity test, two antibiotics, PPI, and bismuth agents were selected, with conventional doses, twice a day

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. There is no restriction on male or female, age 18-70 years old 2. Patients with Helicobacter pylori infection treated at Peking University Shenzhen Hospital 3. All patients were first eradication therapy 4. Patients with clinically diagnosed Helicobacter pylori infection: positive 13C-urea breath test 5. In line with the indications for eradication of Helicobacter pylori in the Fifth National Consensus Report on the Treatment of Helicobacter pylori Infection in 2017

Exclusion criteria

Exclusion criteria: 1. Those who have a history of taking PPI and antibiotics within one month 2. Those with a history of allergy to "penicillin" or a positive skin test for "penicillin" 3. Those with dysphagia, esophageal cancer or stricture, asthma and poor lung function 4. Pregnant women, women who may be pregnant and breastfeeding 5. Acute upper respiratory tract infection, recent active gastrointestinal bleeding, liver cirrhosis and esophageal varices 6. There are other serious diseases that affect the results of this study, such as severe liver disease, cardiovascular disease, respiratory system disease, etc. 7. The patient cannot complain correctly, such as those suffering from mental illness, severe neurosis and those who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication or not;

Secondary

MeasureTime frame
Antibiotic resistance of Helicobacter pylori;

Countries

China

Contacts

Public ContactJun-ping Wang

Peking University Shenzhen Hospital

wjp2006sz@aliyun.com+86 135 1007 6860

Outcome results

None listed

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