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

NCT07650214 | Not Yet Recruiting

• 1 other identifier: SYSU PH (SZ) ME [2026] 041
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.

Conditions

Asymptomatic Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Blood uric acid

  Weeks 0,4,8

Secondary Outcomes (14)

• Blood urea nitrogen

  Weeks 0,4,8

• Blood creatinine

  Weeks 0,4,8

• Blood xanthine

  Weeks 0,8

• Blood hypoxanthine

  Weeks 0,8

• Blood xanthine oxidase

  Weeks 0,8

Study Arms (2)

Probiotic intervention

EXPERIMENTAL

Dietary Supplement: Probiotic

Placebo control

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic products (6 × 10\^9 CFU per day)

Probiotic intervention

Placebo DIETARY_SUPPLEMENT

Placebo (without probiotics, with other ingredients consistent with probiotic products)

Placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The Eighth Affiliated Hospital of Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University

Shenzhen, Guangdong, 518107, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-03

Locations

CN (1)