Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia
23 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
45
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in serum uric acid from baseline
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in uric acid-related metabolites in blood, urine, and feces
Délai: 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
Délai: 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
Délai: 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
|
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Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs)
Délai: 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.
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Throughout 4-week intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 mai 2026
Achèvement primaire (Estimé)
1 mai 2029
Achèvement de l'étude (Estimé)
1 mai 2029
Dates d'inscription aux études
Première soumission
17 avril 2026
Première soumission répondant aux critères de contrôle qualité
23 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Arthropathies cristallines
- Maladies musculo-squelettiques
- Processus pathologiques
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Métabolisme de la purine-pyrimidine, erreurs innées
- Métabolisme, erreurs innées
- Maladies génétiques, innées
- Maladies métaboliques
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Goutte
- Hyperuricémie
Autres numéros d'identification d'étude
- Maanshan_IPE
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Hyperuricémie, Goutte
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