Efficacy of Probiotics Combined with Bismuth-Containing Quadruple Therapy in Patients with Refractory Helicobacter pylori Infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600123681

Enrollment

Unknown

Registered

2026-04-28

Start date

2026-05-10

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

Helicobacter pylori infection

Interventions

Control group:Vonoprazan + Colloidal Bismuth Pectin + Minocycline + Amoxicillin

Experimental group:Bacillus subtilis and Enterococcus faecium live combined preparation+Vonoprazan + Colloidal Bismuth Pectin + Minocycline + Amoxicillin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18–70 years; 2.Diagnosed with refractory Helicobacter pylori infection according to the Sixth National Consensus Report on the Management of Helicobacter pylori Infection, defined as failure to achieve eradication after =2 courses of standard, continuous, and standardized anti-H. pylori regimens with different drug combinations, with a positive ¹³C/¹4C urea breath test (UBT) confirmed after each treatment; 3.No history of antibiotics, probiotics/microecological agents, acid-suppressive medications, or immunosuppressants within the preceding 1 month; 4.An interval of more than 3 months since the completion of the last eradication therapy; 5.Voluntary participation with signed informed consent; this study was approved by the Medical Ethics Committee of our hospital.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergy or hypersensitivity to any of the drugs involved in this study; 2.Pregnant or breastfeeding women; 3.Patients with severe primary diseases of the liver, kidney, heart, brain, lungs, endocrine system, or hematopoietic system, or those diagnosed with malignant tumors; 4.History of drug abuse or alcohol abuse within the preceding 1 year;5.Patients with language disorders or psychiatric disorders; 6.Patients who have participated in or are currently enrolled in other clinical trials within the past 3 months; 7.Other conditions deemed inappropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
Helicobacter pylori eradication rate; Adverse events;	—

Secondary

Measure	Time frame
Compliance;	—

Countries

China

Contacts

Public ContactHu Shengjuan

People's Hospital of Ningxia Hui Autonomous Region

hsj.judy@163.com+86 138 9500 5551

Outcome results

None listed

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