Hyperuricemia, Gout
Conditions
Keywords
Probiotic Intervention, Hyperuricemia, Gout, Urease
Brief summary
This single-center, open-label, two-arm interventional study aims to evaluate the efficacy and safety of a probiotic-uricase complex preparation in patients with hyperuricemia. Participants aged 18 to 60 years with hyperuricemia will be assigned to either the intervention group or the control group. Participants in the intervention group will receive the probiotic-uricase complex preparation during a 2-week treatment period according to the study protocol in addition to conventional management, while participants in the control group will receive conventional management alone. Blood, urine, and fecal samples will be collected at baseline and during follow-up. The primary goal is to assess the change in serum uric acid from baseline after treatment. Secondary assessments include changes in uric acid-related metabolites in blood, urine, and feces, alterations in gut microbiota composition based on metagenomic analysis, and safety outcomes including laboratory parameters and adverse events. This study will explore whether the probiotic-uricase complex may serve as a safe and effective oral intervention for improving uric acid metabolism in patients with hyperuricemia.
Detailed description
This is a single-center, open-label, two-arm interventional clinical study in adults with hyperuricemia. Participants aged 18 to 60 years who meet the study criteria and provide informed consent will be enrolled. The planned sample size is 45 participants, including 30 participants in the intervention group and 15 participants in the control group. Participants in the intervention group will receive the probiotic-uricase complex preparation during a 2-week treatment period according to the study protocol in addition to conventional management, while participants in the control group will receive conventional management alone. Concomitant use of medications or products that may substantially affect gut microbiota or the study intervention, such as antibiotics, immunosuppressive agents, or other microbiome-targeted products, will be restricted according to the protocol. The study consists of a 2-week treatment period followed by a 2-week follow-up period, with assessments performed at Weeks 0, 1, 2, 3, and 4. Clinical and laboratory evaluations will include blood, urine, and fecal sample collection for assessment of uric acid metabolism, related metabolites, gut microbiota composition, and safety parameters. Serum uric acid will be monitored longitudinally to evaluate changes from baseline during treatment and post-treatment follow-up. The primary goal is to assess the effect of the probiotic-uricase complex preparation on serum uric acid in patients with hyperuricemia. Secondary goals are to evaluate changes in uric acid-related metabolites in blood, urine, and feces, explore alterations in gut microbiota composition and uric acid metabolism-related functional profiles based on fecal metagenomic analysis, and assess safety through laboratory testing and adverse event monitoring throughout the study. The results of this study may provide clinical evidence for the use of a probiotic-uricase complex preparation as a novel oral strategy to improve uric acid metabolism in patients with hyperuricemia.
Interventions
DIETARY_SUPPLEMENTProbiotic-uricase complex preparation
Participants receive the probiotic-uricase complex preparation capsule orally. Each participant takes it for 2 weeks. Adherence is monitored through capsule counts and diaries. Clinical and biological evaluations will include blood, urine, and fecal sample collection for assessment of uric acid metabolism, related metabolites, gut microbiota composition, and safety parameters. Serum uric acid will be monitored longitudinally to evaluate changes from baseline during treatment and post-treatment follow-up.
Sponsors
Maanshan Shiqiye Hospital
Institute of Process Engineering, Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No additional masking. This is an open-label study; all participants, investigators, and outcome assessors are aware of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years. * Men with serum uric acid levels \> 420 μmol/L on 2 separate occasions (not on the same day), women with serum uric acid levels \> 360 μmol/L on 2 separate occasions (not on the same day). * Participants must sign an informed consent form and be able to cooperate with sample collection.
Exclusion criteria
* A history of or current presence of a clearly defined organic intestinal disease, such as intestinal malignant tumor, inflammatory bowel disease, intestinal obstruction, or intestinal polyp. * Concurrent severe systemic diseases, including severe cardiovascular or cerebrovascular disease (eg., myocardial infarction within the past 6 months, NYHA Class III-IV heart failure, or uncontrolled hypertension), significant liver function abnormalities (ALT or AST \> 2 times the upper limit of normal), moderate-to-severe renal insufficiency (eGFR \< 45 mL/min/1.73 m²) or uncontrolled diabetes (HbA1c ≥ 9%). * Use of antibiotic, probiotic preparation, or other drugs that may significantly alter the gut microbiota within 4 weeks prior to enrollment, or those requiring continued use of such drugs during the study. * Women who are pregnant or lactating, or who plan to become pregnant during the study. * Participants with severe tophus or gouty nephropathy. * Participants who have participated in another clinical trial within 3 months prior to enrollment. * Participants with other health problems that render them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum uric acid from baseline | Baseline, Weeks 1, 2, 3, and 4 | Change in serum uric acid from baseline to Weeks 1, 2, 3, and 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in uric acid-related metabolites in blood, urine, and feces | Baseline, Weeks 1, 2, 3, and 4 | Changes in uric acid-related metabolites, including uric acid and allantoin, in blood, urine, and fecal samples. |
| Change in gut microbiota composition based on fecal metagenomic analysis | Baseline, Weeks 1, 2, 3, and 4 | Changes in gut microbiota composition and relative abundance of uric acid metabolism-related microorganisms based on fecal metagenomic analysis. |
| Change in uric acid metabolism-related microbial functional genes | Baseline, Weeks 1, 2, 3, and 4 | Changes in the abundance of microbial functional genes related to uric acid metabolism, including genes identified through fecal metagenomic analysis. |
| Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs) | Throughout 4-week intervention | Treatment-emergent adverse events will be monitored throughout the 4-week intervention period. Results will be reported as the number and percentage of participants experiencing adverse events (AEs) after initiation of the probiotic intervention. |
Outcome results
None listed