Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia
23 maj 2026 uppdaterad av: Maanshan Shiqiye Hospital
An Exploratory Clinical Study to Evaluate the Effect of a Probiotic-Uricase Complex Preparation on Serum Uric Acid Reduction and Its Regulation of Gut Microbiota Composition and Uric Acid-Related Metabolic Profiles in Patients With Hyperuricemia
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
45
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Probiotic-uricase complex plus conventional management
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.
|
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.
|
|
Inget ingripande: Conventional management alone
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in serum uric acid from baseline
Tidsram: Baseline, Weeks 1, 2, 3, and 4
|
Change in serum uric acid from baseline to Weeks 1, 2, 3, and 4.
|
Baseline, Weeks 1, 2, 3, and 4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in uric acid-related metabolites in blood, urine, and feces
Tidsram: Baseline, Weeks 1, 2, 3, and 4
|
Changes in uric acid-related metabolites, including uric acid and allantoin, in blood, urine, and fecal samples.
|
Baseline, Weeks 1, 2, 3, and 4
|
|
Change in gut microbiota composition based on fecal metagenomic analysis
Tidsram: 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.
|
Baseline, Weeks 1, 2, 3, and 4
|
|
Change in uric acid metabolism-related microbial functional genes
Tidsram: 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.
|
Baseline, Weeks 1, 2, 3, and 4
|
|
Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs)
Tidsram: 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.
|
Throughout 4-week intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 maj 2026
Primärt slutförande (Beräknad)
1 maj 2029
Avslutad studie (Beräknad)
1 maj 2029
Studieregistreringsdatum
Först inskickad
17 april 2026
Först inskickad som uppfyllde QC-kriterierna
23 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Kristallarthropatier
- Muskuloskeletala sjukdomar
- Patologiska processer
- Artrit
- Ledsjukdomar
- Reumatiska sjukdomar
- Purin-pyrimidinmetabolism, medfödda fel
- Metabolism, medfödda fel
- Genetiska sjukdomar, medfödda
- Metaboliska sjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Gikt
- Hyperurikemi
Andra studie-ID-nummer
- Maanshan_IPE
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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