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A randomized, double-blind, placebo controlled clinical trial to evaluate the safety and efficacy of probiotics supplementing with standard quadruple therapy in the treatment of Helicobacter pylori Infection

A randomized, double-blind, placebo controlled clinical trial to evaluate the safety and efficacy of probiotics supplementing with standard quadruple therapy in the treatment of Helicobacter pylori Infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056575
Enrollment
Unknown
Registered
2022-02-08
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-10-15

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:Placebo + standard quadruple therapy
Experimental group:Probiotics + standard quadruple therapy

Sponsors

The First People's Hospital of Kunshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, no gender limit; 2. Positive C13 urea breath test, rapid urease test, serum Hp antibody or histological examination; 3. Good compliance, able to comply with the requirements of clinical trials; 4. The subject or guardian has signed the informed consent form, basic information questionnaire, and promised to cooperate with the study throughout the trial period.

Exclusion criteria

Exclusion criteria: 1. Patients previously treated with Helicobacter pylori; 2. Patients who had taken antibiotics, proton pump inhibitors, bismuth preparations and some traditional Chinese medicine with antibacterial effect 4 weeks before enrollment; 3. Those who had taken probiotics, prebiotics or synbiotics 2 weeks before enrollment; 4. Previous digestive system surgery (except appendectomy, polypectomy and cholecystectomy); 5. Eradication of allergy or any contraindications with quadruple antibiotic therapy; 6. Severe mental or neurological disorders; 7. Alcohol or drug abusers; 8. Pregnant women or breast-feeding patients; 9. Failed to adhere to treatment and participated in other clinical investigators; 10. Participated in other clinical trials within 4 weeks before enrollment; 11. The doctor judged that the compliance was poor and it was not suitable to participate in the clinical investigator after evaluation; 12. Relevant personnel of this clinical trial study.

Design outcomes

Primary

MeasureTime frame
Eradication rate;Microbiota analysis;

Secondary

MeasureTime frame
The rate of side effects;Patient compliance;

Countries

China

Contacts

Public ContactWu Xiaoyang
pkartest@yeah.net+86 512 57530744

Outcome results

None listed

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