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Clinical efficacy study of Lactobacillus paracasei CPU2306 in the treatment of hyperuricemia

Clinical efficacy study of Lactobacillus paracasei CPU2306 in the treatment of hyperuricemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099978
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Hyperuricemia

Interventions

placebo group:Placebo
Probiotic treatment group:Probiotic treatment
Security Testing Team:Probiotic treatment

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Non same day, twice fasting blood uric acid>420 µ mol/L; 2.Age between >= 18 years old and = 3 months; 4.Not using uric acid lowering drugs within 8 weeks prior to screening; 5.BMI >= 18.5kg/m^2 and <= 35kg/m^2; 6.If hypertension, type 2 diabetes and hyperlipidemia are combined, the medication should be stable 8 weeks before enrollment, and the condition should be controlled stably. During the study period, there is no need to adjust the original treatment drugs. 7.Triglycerides <= 500 mg/dL (5.65 mmol/L); Total cholesterol (TC) <= 250mg/dl (6.45mmol/L). 8.Voluntarily sign an informed consent form before screening and agree to be randomly assigned to any experimental group.

Exclusion criteria

Exclusion criteria: 1.Known allergy constitution or previous allergy to probiotic preparations; 2.Acute gout attack period; 3.Participated in clinical trials of other drugs within 3 months prior to the screening period; 4.Individuals who have taken probiotics or antibiotics within the past 4 weeks prior to screening; 5.Those with poor blood pressure control, i.e. systolic blood pressure (SBP)>160mmHg and/or diastolic blood pressure (DBP)>100mmHg; 6.Triglycerides (TG)>500 mg/dL (5.65 mmol/L) and/or total cholesterol (TC)>250 mg/dL (6.45 mmol/L). 7.Transient cerebral ischemia, cerebrovascular accident, unstable angina, acute pancreatitis, diabetes acute complications or serious diabetes chronic complications occurred within 6 months before screening; History of myocardial infarction, coronary angioplasty or coronary artery bypass surgery in the past; Cardiac dysfunction (NYHA classification III/IV); 8.Having liver diseases such as cirrhosis, active hepatitis, or ALT and AST levels exceeding 2.5 times the upper limit of normal; Severe kidney disease, eGFR< 45ml/min/1.73m^2; 9.Any conditions or comorbidities that researchers determine may interfere with the test results, such as cardiovascular, respiratory, gastrointestinal, pancreatic diseases, liver, kidney, nervous system, psychiatric, hematological, immune system diseases, or other malignant tumors; 10.Screening for drugs that may have a significant impact on uric acid metabolism, such as steroid hormones, immunosuppressants, etc., within the first 4 weeks or expected to be used; 11.Patients with other mental illnesses who are unable or unwilling to cooperate; Or other situations that the researcher deems unsuitable for research.

Design outcomes

Primary

MeasureTime frame
Blood uric acid concentration;

Secondary

MeasureTime frame
Blood inflammatory factor concentration;gut flor;

Countries

China

Contacts

Public ContactXinfeng Bai

Shandong Provincial Third Hospital

sdsldsyykyb@163.com+86 531 8165 6993

Outcome results

None listed

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