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The efficacy and safety of vonoprazan, amoxicillin combined with berberine hydrochloride in rescue treatment for helicobacter pylori eradication: a prospective, randomized controlled study

The efficacy and safety of vonoprazan, amoxicillin combined with berberine hydrochloride in rescue treatment for helicobacter pylori eradication: a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117858
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

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 A:14-day oral medication therapy: Vonoprazan 20mg twice a day, amoxicillin 1000mg three times a day, berberine hydrochloride 500mg twice a day
Group B:14-day oral medication regimen: Vonoprazan 20mg twice a day, amoxicillin 1000mg three times a day
Group C:14-day oral medication regimen: rabeprazole 10mg twice a day, bismuth pectin granules 300mg twice a day, amoxicillin 1000mg twice a day, furazolidone 100mg twice a day

Sponsors

the Ninth People's Hospital of Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Select patients who have failed in eradicated Hp (previous treatment regimens include but are not limited to clarithromycin, metronidazole and/or amoxicillin, etc.) and have been diagnosed as Hp positive after examination aging 18 to 80 years old who visited our hospital. The diagnosis of Hp requires at least one of the following three tests: histopathological examination, 13C urea breath test, or 14C urea breath test. (2) Meet the indications for Hp eradication (as per the "Fifth National Consensus Report on the Management of Helicobacter pylori Infection"). (3) Those who have not used antibiotics, bismuth agents, acid suppressants or other drugs in the 8 weeks prior to treatment. (4) The time interval since the last anti-Hp treatment should be at least half a year. (5) Clearly understand and voluntarily participate in this research, and have the informed consent form signed by themselves or their family members.

Exclusion criteria

Exclusion criteria: (1) Initial treatment patients with Hp infection; (2) The subjects have undergone surgeries such as subtotal gastrectomy or total gastrectomy that may affect gastric acid secretion or drug absorption; (3) Antibiotics, bismuth agents and traditional Chinese medicines with antibacterial activity were taken 4 weeks before treatment, and drugs such as P-CAB, PPI and H2 receptor antagonists were taken 2 weeks before treatment; (4) Those with severe insufficiency of heart, lung, kidney or liver function and low immunity; (5) Pregnant and lactating patients; (6) Those with mental illnesses or communication disorders; (7) Patients who are allergic to the drugs used in the eradication therapy; (8) Patients with a history of gastrointestinal malignancies; (9) Those suffering from hemolytic anemia or hereditary glucose-6-phosphate dehydrogenase deficiency (favism); (9) The guardian or the patient refuses to be enrolled in the group; (10) Those without legal capacity or with poor self-awareness.

Design outcomes

Primary

MeasureTime frame
Eradication rate of Helicobacter pylori;Incidence of adverse reactions;

Secondary

MeasureTime frame
Improvement rate of gastrointestinal symptoms;The changes in the abundance of intestinal flora;Medication compliance rate;Drug expenses of each group;

Countries

China

Contacts

Public ContactLiu Zhang

the Ninth People's Hospital of Chongqing

864835087@qq.com+86 159 7293 9028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026