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GoutNCT06969469

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

An observational study of Gout, run by Grape King Bio Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Gout
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteTaiwan
Study dates
18 Jul 2022to 8 Aug 2024
How long will I take part?
3 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100229

Other trials in Taiwan

About this study

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.

Read the detailed description

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. In recent years, lactic acid bacteria have gradually been recognized to have many benefits for human health, especially in regulating intestinal flora, enhancing immune function, and improving metabolism. Uric acid is a product of purine metabolism in the human body. Excessive uric acid concentration can cause hyperuricemia, which in turn increases the risk of gout attacks. The formation of hyperuricemia is related to multiple factors, including poor eating habits, genetic factors, and metabolic disorders.

As research on intestinal microbiota deepens, scientists have discovered that changes in intestinal flora may have a certain impact on metabolic diseases, including hyperuricemia. As an important type of probiotics, lactic acid bacteria have the ability to improve the structure of intestinal flora, regulate immune response and have anti-inflammatory effects. Recent studies have shown that lactic acid bacteria may play a positive role in reducing uric acid concentration in the blood through various mechanisms, such as degrading purine substances in the intestine, promoting uric acid excretion, and inhibiting uric acid production .

In addition, the function of lactic acid bacteria in regulating the intestinal environment, improving the diversity of intestinal microorganisms and promoting the growth of beneficial bacteria may also indirectly affect the metabolic process of uric acid. Therefore, exploring the potential of lactic acid bacteria in regulating uric acid concentration has become a hot topic in many current studies. These studies not only provide new insights into the health effects of lactic acid bacteria, but also provide new directions for the prevention and treatment of gout and other diseases related to abnormal uric acid.

This study will explore the potential role and mechanism of lactic acid bacteria in lowering uric acid and evaluate its feasibility as an adjuvant therapy.

Conditions
Gout
Being tested
Give the Placebo and test article
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Give the Placebo and test articleDietary 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.

Study groups in NCT06969469
Study groupRoleWhat they receive
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
Receives: Dietary Supplement: Give the Placebo and test article

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 20 Subjects Should be Detected the Value of Uric Acid, Glucose ac, TG, TC, HDL and LDL (Unit: 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. Blood sampling points were week 0, week 2, week 6

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood sampling were at week 0, week 2, week 6.

Secondary outcomes (7)
  1. The 20 Subjects Should be Detected the Value of Hematology: Hct, RDW-CV, Neu, Lym, Mon, Eos, Bas (Unit: %).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

  2. The 20 Subjects Should be Detected the Value of 8 Kinds of Cytokine: IL-1β, IL-6, IL-10, IL-13, IL-17, IL-18, TNF-α, IFN-γ (Unit: pg/mL).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week 0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days. Blood samlping were at week 0, week 2 and week 6.

  3. The 20 Subjects Should be Detected the Value of Hematology: WBC, PLT (Unit: 10^3 Cells/μL).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

  4. The 20 Subjects Should be Detected the Value of Hematology: Hb, MCHC (Unit: g/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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

  5. The 20 Subjects Should be Detected the Value of Hematology: MCV (Unit: fL).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

  6. The 20 Subjects Should be Detected the Value of Hematology: MCH (Unit: pg).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

  7. The 20 Subjects Should be Detected the Value of Hematology:RBC (Unit: 10^6 Cells/μL).

    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.Through the analysis of serum biochemistry, hematology and various cytokines in serum, we can obtain the effects of "LUA probiotics" on the human body after consumption. Blood samlping were at week0, week 2 and week 6.

    Measured: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood samlping were at week0, week 2 and week 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start18 Jul 2022
  3. Primary completion29 Mar 2024
  4. Study completion8 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
Target duration
3 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969469
Sponsor's protocol ID
Grape King Bio Ltd
Status last verified
Jun 2026
First submitted
5 May 2025
Last updated
22 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37599588

Questions about this trial

What is this clinical trial studying?

An observational study of Gout, run by Grape King Bio Ltd. at 1 site in Taiwan.

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 22 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 Taiwan. 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. 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?

Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 20 Subjects Should be Detected the Value of Uric Acid, Glucose ac, TG, TC, HDL and LDL (Unit: mg/dL). (time frame: Phase 1: The 20 subjects take 2 capsules (500 mg/capsule)/Placebo after dinner for 14 days. Phase 2: The same 20 subjects take 2 capsules (500 mg/capsule)/test article after dinner for 28 days.Blood sampling were at week 0, week 2, week 6.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06969469, which also lists 1 linked publication.

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 22 Jun 2026.

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