A comparative study of three modified regimens and standard quadruple regimen for first-line eradication therapy of Helicobacter pylori

Study on the eradication effect of modified program on Helicobacter pylori infection

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050989

Enrollment

Unknown

Registered

2021-09-09

Start date

2021-10-15

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

Helicobacter pylori infection

Interventions

Group 1:Esomeprazole(20mg, bid)+Amoxicillin Capsule(1000mg, bid)+Clarithromycin (500mg, bid)+ Bismuth(Colloidal Bismuth Pectin 200mg, tid)

Group 2:Esomeprazole(20mg, bid)+Amoxicillin Capsule(1000mg, bid)+Berberine (200mg, tid)+ Bismuth(Colloidal Bismuth Pectin 200mg, tid)

Group 3:Esomeprazole(20mg, qid)+Amoxicillin Capsule(750mg, qid)

Group 4:Esomeprazole(20mg, qid)+Amoxicillin Capsule(750mg, qid)+Berberine (200mg, tid)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. 13C-Urea Breath Test (13C-UBT) or pathologically confirmed Hp infection; 3. Patients who receive treatment for the first time and meet the indications for eradication; 4. The patient signed the informed consent and was able to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Past medical history: history of upper gastrointestinal surgery; 2. History of present illness: active ulcer, dysplasia, dysphagia, iron deficiency anemia, vital organ damage, unstable cardiopulmonary disease, endocrine disease, malignant tumor, neurosis; 3. History of treatment and medication: those who have undergone eradication therapy due to Hp infection in the past; those who have used antibiotics, bismuth, H2 receptor antagonists or PPI within 4 weeks; at present, for the purpose of treatment or prevention, long-term use of H2 receptor antagonists or PPIs is required; corticosteroids, NSAIDs, anticoagulation, and antiplatelet aggregation drugs are used; 4. Those who are pregnant or breastfeeding; 5. There are the following conditions for the researched drugs: history of allergies, contraindications to drug use; 6. Unable to cooperate with follow-up; 7. Personal history: history of alcoholism within 1 year.

Design outcomes

Primary

Measure	Time frame
Helicobacter pylori eradication rate by intention-to-treat;Analysis of Helicobacter pylori clearance rate by program;	—

Secondary

Measure	Time frame
Incidence of adverse drug reactions;Compliance;Proportion of six antibiotic resistance genes of clarithromycin, amoxicillin, levofloxacin, metronidazole, tetracycline and furazolidone;	—

Countries

China

Contacts

Public ContactZhang Xiaomei

Chinese PLA General Hospital

zhangxiaomeinew@163.com+86 15801404081

Outcome results

None listed

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