Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia

Starting soon · Not applicable

Conditions studied: Hyperuricemia, Gout

In brief

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.

Key facts

Study ID

NCT07613164

Run by

Maanshan Shiqiye Hospital

People needed

45

Starts

2026-05-01

Expected to finish

2029-05-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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