Not yet recruiting NCT07650214
Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Asymptomatic Hyperuricemia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Probiotic
Probiotic products (6 × 10\^9 CFU per day) - Dietary supplement Placebo
Placebo (without probiotics, with other ingredients consistent with probiotic products)
Primary outcome measures
- Blood uric acid [Time frame: Weeks 0,4,8]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- Sun Yat-sen University — Shenzhen
Identifiers
NCT: NCT07650214 · SYSU PH (SZ) ME [2026] 041