A multicenter, randomized, double-blind, placebo-controlled clinical study of bifidobacterium quadruple viable tablets assisted P-CAB quadruple therapy for refractory Helicobacter pylori infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400090233

Enrollment

Unknown

Registered

2024-09-26

Start date

2024-10-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Helicobacter pylori infection

Interventions

Probiotic group (BQT-P):Vonoprazan 20 mg bid + cefuroxime 500 mg bid + minocycline 100 mg bid + bismuth 220 mg bid + tetralogy of viable bifidobacterium tablets 2.5/2.0g bid for 14 days

Placebo group (BQT) :Vonoprazan 20 mg bid + cefuroxime 500 mg bid + minocycline 100 mg bid + bismuth 220 mg bid + placebo 2.5/2.0g bid for 14 days

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? 18-65 years old, gender unlimited; ? H. pylori infection was diagnosed by 13/14C urea breath test and monoclonal stool antigen test; ? After 2 or more times of failure of H. pylori eradication treatment, =6 months from the end of the last treatment; ? Informed and consented to participate in this study.

Exclusion criteria

Exclusion criteria: ? Failed eradication with 1 or more standard bismuth quadruple therapy consisting of tetracycline or minocycline + cefuroxime; ? History of allergy to minocycline, cefuroxime, or other drugs involved in this study, or detected resistance to both antibiotics in therapy; ? Patients with important underlying diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, abnormal coagulation function, and malignant tumors; ? Complicated with severe gastrointestinal diseases (such as tumors, gastrointestinal bleeding, Zollinger-Ellison syndrome, inflammatory bowel disease, etc.) or history of gastrointestinal surgery; ? PPIs, P-CABs, H2-receptor antagonists, antibiotics, Chinese medicines with antibacterial activity, bismuth, probiotics, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressants, or hormones and other drugs within the last 1 month; ? Have taken laxatives or had acute gastroenteritis in the last 4 weeks; ? In pregnancy or lactation period; ? Those deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Compliance;Gastric mucosal microbiota;Gut microbiota;	—

Countries

China

Contacts

Public ContactLi Peiyuan

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

pyli@tjh.tjmu.edu.cn+86 133 1717 1760

Outcome results

None listed

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