Efficacy of probiotics combined with drug intervention in the treatment of Helicobacter pylori infection

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059817

Enrollment

Unknown

Registered

2022-05-12

Start date

2022-05-10

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Helicobacter pylori infection

Interventions

Placebo group:Standard quadruple therapy + placebo

Test group:Standard quadruple therapy + probiotics

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old; 2. Meet the diagnostic criteria for H. pylori infection in the "Guidelines for Primary Diagnosis and Treatment of Helicobacter pylori Infection (Practical Edition 2019)", that is, those who meet one of the following 3 items can be judged as H. pylori current infection: (1) Gastric mucosal tissue rapid urea Enzyme test (RUT), tissue section staining or bacterial culture positive for any of the 3 items; (2) 13C-urease breath test (13C-UBT) or 14C-UBT showed positive for Helicobacter pylori infection; (3) Positive stool Hp antigen (HpSA) test (clinically validated monoclonal antibody method); positive serum Hp antibody test (clinically validated, high-accuracy reagent), and those who have never been treated; 3. Voluntarily participate in this experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 or over 65 years old; 2. Those who are currently pregnant, breastfeeding or trying to conceive; 3. Those with mental illness, immune system disease, cardiovascular, lung, liver, kidney disease, malignant tumor, coagulation disorder, etc; 4. Those who are contraindicated to the research drug; 5. Those with a history of previous treatment for Helicobacter pylori infection; 6. Those who have used antibiotics, probiotics, proton pump inhibitors, H2 receptor antagonists, bismuth preparations, laxatives, antidiarrheals or some antibacterial Chinese medicines within 4 weeks; 7. Those with a history of gastrointestinal surgery; 8. Subjects deemed unsuitable for this study by clinicians, and subjects participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Hp eradicate rate;Gastrointestinal symptom score;	—

Secondary

Measure	Time frame
Serum inflammatory factors;Gastrointestinal hormone;Gut flora;Intestinal metabolites;Blood metabolome;	—

Countries

China

Contacts

Public ContactJingjing He

China Agricultural University

hejingjing_89@163.com+86 15120092404

Outcome results

None listed

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