Hyperuricemia
Conditions
Interventions
Placebo control group:Take one placebo capsule containing a 1:1 mixture of potato starch and pregelatinized starch daily for 12 consecutive weeks.
BL-G301 single-strain intervention group:Take one capsule containing 1×10^10 CFU of Bifidobacterium longum subsp. longum BL-G301 daily for 12 consecutive weeks.
LA-G80 single-strain intervention group:Take one capsule containing 1×10^10 CFU Lactobacillus acidophilus LA-G80 daily for 12 consecutive weeks.
BL-G301+LA-G80 dual-strain intervention group:Take one capsule daily containing 1×10^10 CFU of a 1:1 blend of Bifidobacterium longum subsp. longum BL-G301 and Lactobacillus acidophilus LA-G80 for 12 c
Sponsors
Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, either sex, with a BMI>18.5; 2.Under a normal diet, fasting serum uric acid levels measured on two separate occasions are 420–540 µmol/L in men and 360–540 µmol/L in women; 3. Maintained relatively stable dietary habits and lifestyle during the 4 weeks prior to enrollment and is willing to maintain them throughout the study period; 4. Able to swallow capsules; 5. Voluntarily agrees to participate in the clinical trial, willing to sign the informed consent form, complete questionnaires, and adhere to the schedule for follow-up visits and sample collection.
Exclusion criteria
Exclusion criteria: 1. Secondary hyperuricemia caused by kidney disease, hematologic disorders, medications, radiation/chemotherapy for tumors, organ transplantation, or other causes; 2. Use of urate-lowering drugs (e.g., allopurinol, febuxostat, etc.) within 4 weeks prior to enrollment; 3. Use of antibiotics or probiotic preparations (e.g., Miya, Peifeikang, etc.) within 4 weeks prior to enrollment; 4. Continuous oral corticosteroid use for 10 days or more within 4 weeks prior to enrollment, or intramuscular, subcutaneous, or intra-articular corticosteroid injections within 4 weeks prior to screening; 5. Current use or requirement of diuretics; 6. Current use or requirement of anticoagulants (e.g., aspirin, other salicylates, heparin, warfarin) or antiplatelet agents (e.g., clopidogrel or ticlopidine); 7.Recent acute gout attack or a requirement for frequent nonsteroidal anti-inflammatory drugs (NSAIDs) or hormone therapy for control; 8. History of alcohol or substance abuse, or daily analgesic use for any reason; 9. Severe cardiovascular/cerebrovascular events, malignancy, immunodeficiency, psychiatric disorders, etc; 10. Abnormal renal function (serum creatinine [SCr] levels exceeding twice the upper limit of normal) or abnormal hepatic function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or gamma-glutamyltransferase [GGT] levels exceeding twice the upper limit of normal); 11. Pregnancy, lactation, or plans to conceive within 4 weeks after the last dose of study medication; 12. Allergy to dairy products or study product excipients; 13. Participation in another clinical trial within the past three months or concurrent participation in another trial; 14. Other reasons deemed unsuitable for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum uric acid levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate for hyperuricemia;Anthropometric parameters (height, weight, and BMI, etc.);Renal function parameters (urinary creatinine, serum creatinine, urea nitrogen, etc.) ;Liver function parameters (aspartate aminotransferase, alanine aminotransferase, albumin, etc.) ;Inflammatory markers (Interleukin-6, tumor necrosis factor-a, C-reactive protein, etc.));Metabolic parameters (blood glucose, glycated hemoglobin, triglycerides, total cholesterol, etc.);Multi-omics–related outcomes (fecal metagenomics, proteomics and metabolomics); | — |
Countries
China
Contacts
Public ContactZhao Yueliang
School of Public Health, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed