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A Multicenter, Prospective Real-World Study on Bifidobacterium-Lactobacillus Triple Live Bacteria Tablets (Jinshuangqi) for Reducing the Incidence of Gastrointestinal Adverse Reactions During Eradication Therapy for Helicobacter Pylori Infection

A Multicenter, Prospective Real-World Study on Bifidobacterium-Lactobacillus Triple Live Bacteria Tablets (Jinshuangqi) for Reducing the Incidence of Gastrointestinal Adverse Reactions During Eradication Therapy for Helicobacter Pylori Infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108063
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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:None
observation group:None

Sponsors

Shenzhen Hospital of Southern Medical Unversity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, regardless of gender; 2. Identified as Hp-positive by 13C/14C-urea breath test; 3.Judged by researchers to require Hp eradication therapy, and the 14-day quadruple bismuth-containing regimen (proton pump inhibitor/P-CAB + bismuth + antibiotic combination) or high-dose dual therapy is selected; 4.(No previous Hp eradication therapy; 5. Willing to receive Hp eradication therapy and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Complicated with severe primary diseases in the hematological, renal, respiratory, digestive, nervous systems or other systems that significantly affect life expectancy; complicated with malignant tumors, mental illnesses, or immunodeficiency diseases expectancy; 2.(2) Having taken oral antibiotics or steroid hormones within 4 weeks before enrollment, or oral acid suppressants within 2 weeks before enrollment; 3.(3) Having taken, or planning to take, other probiotic preparations or yogurt (other than the study drug) within 1 week before enrollment or during the study period; 4.(4) Pregnant or lactating women; 5.(5) Those allergic to probiotics; 6.(6) Patients deemed unsuitable for inclusion in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Incidence rate of digestive tract adverse reactions related to Hp eradication therapy;

Secondary

MeasureTime frame
Hp eradication rate;Duration of total adverse reactions and each individual adverse reaction;Incidence rate of each individual adverse reaction;Incidence rate of adverse reactions;Medication compliance;Changes in SF-6D scale and EQ-5D scores of quality of life scales compared with baseline;Severity of each individual adverse reaction;

Countries

China

Contacts

Public ContactChenye

Shenzhen Hospital of Southern Medical Unversity

yechen@smu.edu.cn+86 20 61641543

Outcome results

None listed

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