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A randomized, double-blind, placebo controlled clinical trial to evaluate the safety and efficacy of Bifidobacterium Tetravaccine Tablets supplementing with dual therapy in the treatment of Helicobacter pylori Infection and the effects on gastrointestinal microecology

A randomized, double-blind, placebo controlled clinical trial to evaluate the safety and efficacy of Bifidobacterium Tetravaccine Tablets supplementing with dual therapy in the treatment of Helicobacter pylori Infection and the effects on gastrointestinal microecology

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060023
Enrollment
Unknown
Registered
2022-05-15
Start date
2021-12-27
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Helicobacter pylori

Interventions

group VB :Vonolasone fumarate (Walker) 20mg, bid+ Amoxicillin 750mg, qid+ Bifidobacterium Tetravaccine Tablets 3 tablets, tid
group VP :Vonolasone fumarate (Walker) 20mg, bid+ Amoxicillin 750mg, qid+ Bifidobacterium Tetravaccine Tablets Placebo 3 tablets, tid

Sponsors

Department of Gastroenterology, Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years; No gender limit; 2. Patients who are diagnosed with Helicobacter pylori; 3. Patients who have not received Helicobacter pylori eradication treatment in the past, or who have failed to eradicate in the early stage but have not received eradication treatment within half a year; 4. Voluntarily participate in this experiment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to the study drug (penicillin allergy, etc.); 2. Patients with chronic gastritis accompanied by peptic ulcer; 3. Patients who have received Helicobacter pylori eradication treatment within six months; 4. Antibiotics, bismuth and probiotics were used 4 weeks before treatment, and histamine H2 receptor antagonists, PPI or potassium competitive acid blockers were used 2 weeks before treatment; 5. Use adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnant and lactating patients; 8. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease, tumor; 9. Drink too much.

Design outcomes

Primary

MeasureTime frame
H.pylori eradication rate;Adverse reaction assessment;

Countries

China

Contacts

Public ContactZhang Zhenyu
zzy6565@sina.com+86 18951670222

Outcome results

None listed

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