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

NCT07613164 | Not Yet Recruiting

• 1 other identifier: Maanshan_IPE
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperuricemia, Gout

Keywords

Probiotic Intervention; Hyperuricemia; Gout; Urease

Outcome Measures

Primary Outcomes (1)

• Change in serum uric acid from baseline

  Change in serum uric acid from baseline to Weeks 1, 2, 3, and 4.

  Baseline, Weeks 1, 2, 3, and 4

Secondary Outcomes (4)

• Change in uric acid-related metabolites in blood, urine, and feces

  Baseline, Weeks 1, 2, 3, and 4

• Change in gut microbiota composition based on fecal metagenomic analysis

  Baseline, Weeks 1, 2, 3, and 4

• Change in uric acid metabolism-related microbial functional genes

  Baseline, Weeks 1, 2, 3, and 4

• Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs)

  Throughout 4-week intervention

Study Arms (2)

Probiotic-uricase complex plus conventional management

EXPERIMENTAL

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

Conventional management alone

NO INTERVENTION

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.

Interventions

Probiotic-uricase complex preparation DIETARY_SUPPLEMENT

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.

Probiotic-uricase complex plus conventional management

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Maanshan Shiqiye Hospital: lead
• Institute of Process Engineering, Chinese Academy of Sciences: collaborator

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional masking. This is an open-label study; all participants, investigators, and outcome assessors are aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share