Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals

June 11, 2026 updated by: Huicui Meng, Sun Yat-sen University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo control
Dietary supplement: Placebo
Placebo (without probiotics, with other ingredients consistent with probiotic products)
Experimental: Probiotic intervention
Dietary supplement: Probiotic
Probiotic products (6 × 10^9 CFU per day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood uric acid
Time Frame: Weeks 0,4,8
Weeks 0,4,8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood urea nitrogen
Time Frame: Weeks 0,4,8
Weeks 0,4,8
Blood creatinine
Time Frame: Weeks 0,4,8
Weeks 0,4,8
Blood xanthine
Time Frame: Weeks 0,8
Weeks 0,8
Blood hypoxanthine
Time Frame: Weeks 0,8
Weeks 0,8
Blood xanthine oxidase
Time Frame: Weeks 0,8
Weeks 0,8
Fecal uric acid
Time Frame: Weeks 0,8
Weeks 0,8
Fecal allantoin
Time Frame: Weeks 0,8
Weeks 0,8
Urine uric acid
Time Frame: Weeks 0,8
Weeks 0,8
Urine allantoin
Time Frame: Weeks 0,8
Weeks 0,8
Serum diamine oxidase
Time Frame: Weeks 0,8
Weeks 0,8
Urine oxidative stress indicator level
Time Frame: Weeks 0,8
Weeks 0,8
Blood inflammatory cytokine levels
Time Frame: Weeks 0,8
Quantitative measurement of chronic inflammatory biomarkers in blood serum or plasma, such as high-sensitivity C-reactive protein (hs-CRP).
Weeks 0,8
Fecal gut microbiota
Time Frame: Weeks 0,8
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.
Weeks 0,8
Metabolomics
Time Frame: Weeks 0,8
Non-targeted metabolomics using LC-MS (liquid chromatography-mass spectrometry).
Weeks 0,8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Eighth Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSU PH (SZ) ME [2026] 041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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