To Evaluate the Influence of (LUA Probiotics) on Uric Acid

NCT06969469 | Completed

• 1 other identifier: Grape King Bio Ltd
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy of the lactic acid bacteria "LUA probiotics" in reducing serum uric acid levels. The use of health supplements prior to the onset of gout symptoms is proposed as a preventive strategy to mitigate the development of gout and to reduce the subsequent reliance on long-term pharmacological treatments. Hyperuricemia is the presence of abnormally high levels of uric acid in the blood serum. Long-term hyperuricemia is a major factor in causing gout. In addition, hyperuricemia is associated with many diseases. Therefore, the prevention and treatment of hyperuricemia has gradually attracted attention. In recent years, studies have pointed out that whether from cell experiments or animal experiments, lactic acid bacteria (LAB) have the effect of lowering uric acid. However, there is a lack of rigorous clinical observational studies to further explore whether lactic acid bacteria really have the effect of lowering uric acid. This product "LUA Probiotics" is a probiotic developed and produced by the Longtan Branch of Grape King Biotechnology Co., Ltd. Its main ingredients include Lactobacillus reuteri (Lactobacillus reuteri), β-carotene, silicon dioxide and magnesium stearate. This product is not yet commercially available.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• The 20 subjects should be detected the value of uric acid (mg/dL), glucose ac (mg/dL), TG (mg/dL), TC (mg/dL), HDL (mg/dL) and LDL (mg/dL).

  This study aims to evaluate whether taking lactic acid bacteria "LUA probiotics" can reduce blood uric acid levels, and prevent gout symptoms by taking health foods before they occur, avoiding the need to take medication later.

  Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days.

Secondary Outcomes (1)

• The 20 subjects should be detected the value of uric acid (mg/dL), glucose ac (mg/dL), TG (mg/dL), TC (mg/dL), HDL (mg/dL), LDL (mg/dL), hematology (14 items) and 8 kinds of cytokine: IL-1β, IL-6, IL-10, IL-13, IL-17, IL-18, TNF-α, IFN-γ (Unit: pg/mL).

  Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days.

Study Arms (1)

Patients with hyperuricemia (uric acid level 7.5 mg/dL or above)

Patients with hyperuricemia (uric acid level 7.5 mg/dL or above) who are not taking uric acid-lowering drugs, patients with gout who are not taking uric acid-lowering drugs

Dietary Supplement: Give the Placebo and test article

Interventions

Give the Placebo and test article DIETARY_SUPPLEMENT

Phase 1: The subjects take 2 capsules (500 mg/capsule)/Placebo after dinner every day for 14 days. Phase 2: The subjects take 2 capsules (500 mg/capsule)/test article after dinner every day for 28 days.

Patients with hyperuricemia (uric acid level 7.5 mg/dL or above)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Collect 20 people, both male and female, aged 20 or above. 2. Be conscious, willing to participate in the clinical observational research project, and complete the signed written consent form. 3. Patients with hyperuricemia (uric acid level above 7.5 mg/dL) who have not taken uric acid-lowering drugs, and patients with gout who have not taken uric acid-lowering drugs, regardless of gender.

You may qualify if:

• Collect 20 people, both male and female, aged 20 or above.
• Be conscious, willing to participate in the clinical observational research project, and complete the signed written consent form.
• Patients with hyperuricemia (uric acid level above 7.5 mg/dL) who have not taken uric acid-lowering drugs, and patients with gout who have not taken uric acid-lowering drugs, regardless of gender.

You may not qualify if:

• Patients diagnosed by a physician as suffering from a major injury or illness listed by the National Health Insurance Administration.
• Pregnant women or women who plan to become pregnant within six months.
• Patients with abnormal liver function (AST, ALT greater than 2 times the upper limit of normal).
• Patients with abnormal renal function (serum creatinine \> 1.5 mg/dL).
• Patients with gastrointestinal dysfunction (surgery, frequent diarrhea).
• Those who must continue to take antibiotics, histamine-2 antagonists, proton pump inhibitors, antioxidants, probiotics, laxatives and other drugs.
• Patients with serious complications such as stroke, myocardial infarction, or major trauma or surgery in the past six months.
• People who are allergic to Lactobacillus.
• Subjects who are unable to exercise their right to consent on their own.
• Those who have irregular eating habits and are unable to cooperate with the plan implementation.
• Those who have poor compliance with doctor's orders.

Sponsors & Collaborators

• Grape King Bio Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

Related Publications (1)

• Cheng S, Shan L, You Z, Xia Y, Zhao Y, Zhang H, Zhao Z. Dietary patterns, uric acid levels, and hyperuricemia: a systematic review and meta-analysis. Food Funct. 2023 Aug 29;14(17):7853-7868. doi: 10.1039/d3fo02004e.

  PMID: 37599588 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Min-Chih Hsu, Master

  Super Laboratory Co., Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: July 18, 2022
• Primary Completion: March 29, 2024
• Study Completion: August 8, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)