Positive Helicobacter pylori (Hp) infection confirmed by 13C/14C urea breath test or histopathological examination within 3 months
Conditions
Interventions
Control group:JUNXIAOBAO Solid Beverage (Prebiotic)
Experimental group:Yin Xiaobao Space 2 Solid Probiotic Beverage, Shu You Probiotic Powder Drink
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–65 years, regardless of sex; 2. Permanent residents who have lived locally for at least 6 months; 3. Helicobacter pylori (Hp) infection confirmed by a ^13C/^14C urea breath test or histopathological examination; 4. Patients with or without upper gastrointestinal symptoms, including but not limited to abdominal pain, abdominal distension, belching, acid regurgitation, and heartburn; 5. No prior history of Hp eradication therapy; 6. During the study period, participants agree not to take any medications, dietary supplements, or other dairy products, including yogurt beverages; 7. Willingness to comply with all study requirements and procedures; 8. Agreement not to participate in other clinical studies during the trial period; 9. Ability to fully understand the nature, purpose, benefits, and potential risks or adverse effects of the study, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any investigational product used in this study; 2. Use of medications involved in Hp eradication regimens within the past 4 weeks, including H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs); 3. History of long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs); 4. Presence of any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, genitourinary, hematological, coagulation, immunological, metabolic, or other medical conditions that, in the investigator’s judgment, may interfere with study outcomes or compromise subject safety; 5. Patients with malignant tumors; 6. History of upper gastrointestinal surgery; 7. Pregnant or lactating women, or women planning to become pregnant within 3 months; 8. Individuals with poor compliance or inability to adhere to study procedures; 9. Participation in other clinical trials at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C13 Breath Test;Serum interleukin-6 (IL-6) level;"Gastrointestinal Symptom Rating Scale" (GSRS), "Enteral Nutrition Tolerance Rating Scale";Serum tumor necrosis factor-alpha (TNF-a) level;Gut microbiota diversity and composition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver and renal function parameters (ALT, AST, creatinine, BUN, uric acid); | — |
Countries
China
Contacts
Public ContactWang Man
Shanghai Fengxian District Central Hospital
Outcome results
None listed