An interventional study of Probiotic-uricase complex preparation in Hyperuricemia, Gout, sponsored by Maanshan Shiqiye Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Maanshan Shiqiye Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants in the intervention group will receive the probiotic-uricase complex preparation during a 2-week treatment period in addition to conventional management. A 2-week follow-up period will follow treatment, with assessments at Weeks 0, 1, 2, 3, and 4. Participants maintain their usual diet and avoid additional probiotics or antibiotics. 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.
Dietary Supplement: Probiotic-uricase complex preparation
Participants will receive conventional management alone without the probiotic-uricase complex preparation. Assessments will be conducted at Weeks 0, 1, 2, 3, and 4. Participants maintain their usual diet and avoid additional probiotics or antibiotics. 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.
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.
Change in serum uric acid from baseline
Change in serum uric acid from baseline to Weeks 1, 2, 3, and 4.
Time frame: Baseline, Weeks 1, 2, 3, and 4
Change in uric acid-related metabolites in blood, urine, and feces
Changes in uric acid-related metabolites, including uric acid and allantoin, in blood, urine, and fecal samples.
Time frame: Baseline, Weeks 1, 2, 3, and 4
Change in gut microbiota composition based on fecal metagenomic analysis
Changes in gut microbiota composition and relative abundance of uric acid metabolism-related microorganisms based on fecal metagenomic analysis.
Time frame: Baseline, Weeks 1, 2, 3, and 4
Change in uric acid metabolism-related microbial functional genes
Changes in the abundance of microbial functional genes related to uric acid metabolism, including genes identified through fecal metagenomic analysis.
Time frame: Baseline, Weeks 1, 2, 3, and 4
Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs)
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.
Time frame: Throughout 4-week intervention
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Maanshan Shiqiye Hospital