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A randomized, double-blind, placebo-controlled trial study of ZC-URA ? composite lactobacillus powder for patients with hyperuricemia (with or without gout)

A randomized, double-blind, placebo-controlled trial study of ZC-URA ? composite lactobacillus powder for patients with hyperuricemia (with or without gout)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096029
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Hyperuricemia (with or without gout)

Interventions

Test group:ZC-URA ? composite lactic acid bacteria powder (specification: 2g/strip), diluted with water below 40 ? and consumed. 2 times a day, 1 piece each time, to be consumed after meals (breakfast
control group:ZC-URA ? Compound Lactic Acid Bacteria Powder Simulator (Specification: 2g/strip), diluted with water below 40 ? and consumed. 2 times a day, 1 piece each time, to be consumed after meal

Sponsors

Guangdong Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 18-75 years old (including boundary values), gender not limited; 2. Blood uric acid level>450 µ mol/L on two non same day fasting periods of 5-6 hours (the first blood uric acid test can accept test results within 3 months); 3. The subjects are informed, voluntarily sign the informed consent form, and agree to participate in all visits, examinations, and treatments according to the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Secondary hyperuricemia caused by kidney disease, blood disease, or the use of certain trial foods, tumor radiotherapy and chemotherapy, organ transplantation, etc; 2. Patients with acute gout attacks or those with acute gout attacks within the past 2 weeks; 3. Merge patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system and other serious primary diseases, malignant tumors, and mental illnesses; Individuals with abnormal liver and kidney function (ALT, AST>1.5ULN; Scr>1.5ULN); 4. Patients with severe hypertension (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg); Type I diabetes or poorly controlled type II diabetes (fasting blood glucose >= 8.5 mmol/L); 5. Individuals with a body mass index (BMI) greater than 30kg/m^2; 6. Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease, and habitual diarrhea; 7. Individuals with a history of taking antibiotics within the past week; Medications that affect uric acid metabolism or excretion and cannot be discontinued within one week, including azathioprine, 6-mercaptopurine, thiazide diuretics, aspirin (over 325mg/day), or other salicylates; 8. Those who require continuous prednisone treatment; 9. Pregnant and lactating women; 10. Allergic constitution or history of allergies to lactobacilli and their products; 11. Participated in other population intervention studies within 3 months prior to the screening period; 12. Other researchers believe that they are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Serum uric acid control compliance rate (= baseline level) after stopping trial feeding for 4 weeks;

Countries

China

Contacts

Public ContactZheng Shaoling

Guangdong Second People's Hospital

ling849@qq.com+86 137 5175 6233

Outcome results

None listed

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