Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia
2026년 5월 23일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
45
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
|
간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum uric acid from baseline
기간: Baseline, Weeks 1, 2, 3, and 4
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Change in serum uric acid from baseline to Weeks 1, 2, 3, and 4.
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Baseline, Weeks 1, 2, 3, and 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in uric acid-related metabolites in blood, urine, and feces
기간: Baseline, Weeks 1, 2, 3, and 4
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Changes in uric acid-related metabolites, including uric acid and allantoin, in blood, urine, and fecal samples.
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Baseline, Weeks 1, 2, 3, and 4
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Change in gut microbiota composition based on fecal metagenomic analysis
기간: Baseline, Weeks 1, 2, 3, and 4
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Changes in gut microbiota composition and relative abundance of uric acid metabolism-related microorganisms based on fecal metagenomic analysis.
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Baseline, Weeks 1, 2, 3, and 4
|
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Change in uric acid metabolism-related microbial functional genes
기간: Baseline, Weeks 1, 2, 3, and 4
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Changes in the abundance of microbial functional genes related to uric acid metabolism, including genes identified through fecal metagenomic analysis.
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Baseline, Weeks 1, 2, 3, and 4
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Safety and tolerability: Incidence of treatment-emergent Adverse Events (AEs)
기간: Throughout 4-week intervention
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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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2029년 5월 1일
연구 완료 (추정된)
2029년 5월 1일
연구 등록 날짜
최초 제출
2026년 4월 17일
QC 기준을 충족하는 최초 제출
2026년 5월 23일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 23일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Maanshan_IPE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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