Asymptomatic HyperuricemiaNCT07650214
Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals
A study testing Probiotic in people with Asymptomatic Hyperuricemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Hyperuricemia
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65;
- Residents who have lived in Guangdong for more than one year;
- According to the "Chinese Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases (2023 Edition)", asymptomatic HUA is defined as a fasting serum uric acid level >420 umol /L and no history of gout symptoms such as gouty arthritis;
- Consent to be randomly assigned to the intervention or control group;
- Willing to consume the probiotic products provided by the study;
Who cannot join
- Secondary HUA caused by disease or drugs;
- Within 3 months before participating in the study, or currently taking drugs that affect uric acid metabolism, such as azathioprine, thiazide diuretics, prednisone, etc., and unwilling to stop taking them during the study;
- Taking or currently taking medication for gout within 3 months before participating in the study and unwilling to stop taking it during the study;
- Abnormal liver function (AST or ALT levels are more than 3 times the upper limit of normal), abnormal renal function (glomerular filtration rate less than 60mL/min/1.73m^2);
- Abnormal blood test results (such as white blood cell count < 3.5x10^9 /L, platelet count < 100x10^9 /L, hemoglobin < 90g/L) or other blood system diseases;
- Suffering from severe cardiovascular, kidney, gastrointestinal, hepatal, and malignant tumor diseases;
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- Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and inability to stop using these drugs within 72 hours before the start of the study;
- Currently taking anticoagulants, anabolic steroids, hydrocortisone and other hormonal drugs;
- Use of probiotic supplements within one month prior to participating in the study, and was unwilling to discontinue taking them during the study;
- Frequent use (more than once a day) of multivitamins, antioxidants, herbal supplements, dietary fiber-containing supplements, and other nutritional supplements (such as inulin, fish oil, soy lecithin, niacin, dietary fiber, flaxseed, phytoestrogens, sterols, etc.), or products containing prebiotics, probiotics, synbiotics, postbiotics, etc. (such as yogurt, fermented milk, beverages, or other fermented products) within 3 months prior to study participation, and unwilling to stop taking them;
- Self-reported weight loss of more than 7 kg or 10% in the 6 months prior to enrollment;
- Suffering from eating disorders (such as anorexia and bulimia), dysphagia, or difficulty swallowing food or medication;
- Unable to consume the probiotic products provided by the study as required during the study period;
- Drink more than 2 times a day, more than 14 times a week, and are unwilling to stop drinking during the study;
- Intolerance or food allergy related to the investigational product, drug allergy, or other issues that may affect food intake;
- Poor venous access;
- Women who have given birth in the past year, are pregnant, or plan to become pregnant within 6 months, or are breastfeeding;
- Participating or planning to participate in other dietary intervention studies, drug use studies, or cosmetic or pharmaceutical application studies in the next three months;
- Participated in clinical trials in the past 3 months;
- Any other condition that is deemed unsuitable for the trial by a physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University
Shenzhen, Guangdong, 518107
Mo Lv, 86+13538032737, lvmo@mail2.sysu.edu.cn
About this study
This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.
- Conditions
- Asymptomatic Hyperuricemia
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic products (6 × 10^9 CFU per day)
PlaceboDietary supplement
Placebo (without probiotics, with other ingredients consistent with probiotic products)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic intervention | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| Placebo control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood uric acid
Measured: Weeks 0,4,8
Secondary outcomes (14)
Blood urea nitrogen
Measured: Weeks 0,4,8
Blood creatinine
Measured: Weeks 0,4,8
Blood xanthine
Measured: Weeks 0,8
Blood hypoxanthine
Measured: Weeks 0,8
Blood xanthine oxidase
Measured: Weeks 0,8
Fecal uric acid
Measured: Weeks 0,8
Fecal allantoin
Measured: Weeks 0,8
Urine uric acid
Measured: Weeks 0,8
Urine allantoin
Measured: Weeks 0,8
Serum diamine oxidase
Measured: Weeks 0,8
Urine oxidative stress indicator level
Measured: Weeks 0,8
Blood inflammatory cytokine levels
Quantitative measurement of chronic inflammatory biomarkers in blood serum or plasma, such as high-sensitivity C-reactive protein (hs-CRP).
Measured: Weeks 0,8
Fecal gut microbiota
Analyzing the composition of gut microbiota using metagenomic sequencing technology. DNA will be extracted from fecal samples using commercial kits, followed by library preparation and sequencing.
Measured: Weeks 0,8
Metabolomics
Non-targeted metabolomics using LC-MS (liquid chromatography-mass spectrometry).
Measured: Weeks 0,8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The Eighth Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Principal investigator, Huicui Meng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650214
- Sponsor's protocol ID
- SYSU PH (SZ) ME [2026] 041
- Status last verified
- Mar 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals
- ClinicalTrials.gov ID
- NCT07650214
- Acronym / sponsor ID
- SYSU PH (SZ) ME [2026] 041
- Conditions
- Asymptomatic Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- The Eighth Affiliated Hospital of Sun Yat-sen University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic intervention | Experimental | Dietary Supplement: Probiotic |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18-65;
- Residents who have lived in Guangdong for more than one year;
- According to the "Chinese Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases (2023 Edition)", asymptomatic HUA is defined as a fasting serum uric acid level >420 umol /L and no history of gout symptoms such as gouty arthritis;
- Consent to be randomly assigned to the intervention or control group;
- Willing to consume the probiotic products provided by the study;
Key exclusion criteria (20 listed)
- Secondary HUA caused by disease or drugs;
- Within 3 months before participating in the study, or currently taking drugs that affect uric acid metabolism, such as azathioprine, thiazide diuretics, prednisone, etc., and unwilling to stop taking them during the study;
- Taking or currently taking medication for gout within 3 months before participating in the study and unwilling to stop taking it during the study;
- Abnormal liver function (AST or ALT levels are more than 3 times the upper limit of normal), abnormal renal function (glomerular filtration rate less than 60mL/min/1.73m^2);
- Abnormal blood test results (such as white blood cell count < 3.5x10^9 /L, platelet count < 100x10^9 /L, hemoglobin < 90g/L) or other blood system diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic products (6 × 10^9 CFU per day) | Dietary supplement | Probiotic intervention |
| PlaceboPlacebo (without probiotics, with other ingredients consistent with probiotic products) | Dietary supplement | Placebo control |
Primary outcome
Blood uric acid
Time frame: Weeks 0,4,8
14 secondary outcomes
Blood urea nitrogen
Time frame: Weeks 0,4,8
Blood creatinine
Time frame: Weeks 0,4,8
Blood xanthine
Time frame: Weeks 0,8
Blood hypoxanthine
Time frame: Weeks 0,8
Blood xanthine oxidase
Time frame: Weeks 0,8
Fecal uric acid
Time frame: Weeks 0,8
Fecal allantoin
Time frame: Weeks 0,8
Urine uric acid
Time frame: Weeks 0,8
Urine allantoin
Time frame: Weeks 0,8
Serum diamine oxidase
Time frame: Weeks 0,8
Urine oxidative stress indicator level
Time frame: Weeks 0,8
Blood inflammatory cytokine levels
Time frame: Weeks 0,8
Fecal gut microbiota
Time frame: Weeks 0,8
Metabolomics
Time frame: Weeks 0,8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Asymptomatic Hyperuricemia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood uric acid (time frame: Weeks 0,4,8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.