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

23. mai 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Probiotic-uricase complex preparation
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in serum uric acid from baseline
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in uric acid-related metabolites in blood, urine, and feces
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Maanshan Shiqiye Hospital

Samarbeidspartnere

Institute of Process Engineering, Chinese Academy of Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. mai 2029

Studiet fullført (Antatt)

1. mai 2029

Datoer for studieregistrering

Først innsendt

17. april 2026

Først innsendt som oppfylte QC-kriteriene

23. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Maanshan_IPE

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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