Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial

Study Overview
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Brief Summary
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Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.

Official Title
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Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Drug: uric-acid-lowering drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible for inclusion in this study only if they meet all of the following criteria 18-70 years old, gender unlimited ； Previous history of gout ； According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015； fasting serum uric acid ≥ 480 μ mol / L (8mg / dl) Exclusion Criteria: If the subjects meet any of the following criteria, they will not be selected ： Gout in the past two weeks ； Secondary hyperuricemia ； Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value； WBC < 4.0 × 109 / L, PLT < 100 × 109 / L, HGB < 90g / L, or other hematological diseases ； bad blood pressure control (BP>160mmHg/100 mmHg) Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ； Patients with active peptic ulcer ； Patients with gastrointestinal cancer ； Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ； Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ； Those who need continuous prednisone treatment ； Those who need antibiotic treatment for infectious diseases ； Those with body mass index (BMI) greater than 30 ； people with alcoholism ； People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ； Researchers who have received other drugs within 3 months before screening ； The people who are researchers thinks it is not suitable to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Dietary Supplement: Probiotics<br>* Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.<br>Drug: uric-acid-lowering drug<br>* Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.<br>|
| Placebo Comparator: Control group<br> | Drug: uric-acid-lowering drug<br>* Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum uric acid level | The serum uric acid level was standard-reaching rate at the end of 24 weeks(Percentage of patients whose serum uric acid level has decreased to less than 360umol / L ) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum uric acid level at the 4、8、12、24 weeks | the serum uric acid level and the percentage of patients with < 360umol / L at the end of 4, 8, 12 and 24 weeks after treatment | 4、8、12、24 weeks | 
| serum uric acid decreased from baseline | At the end of 4, 8, 12 and 24 weeks after treatment, the serum uric acid level decreased from baseline | 4、8、12、24 weeks | 
| Acute attack of gout | Number of acute gout attacks during 24 weeks of treatment | 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gout, hyperuricemia, probiotics