Gout, Hyperuricemia
Conditions
Keywords
gout, hyperuricemia, probiotics
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Sponsors
Inner Mongolia University of Science and Technology
Inner Mongolia Hulunboir hospital
Inner Mongolia People's Hospital
Inner Mongolia Ordos Central Hospital
Inner Mongolia Baogang Hospital
Inner Mongolia Medical College
The Affiliated Hospital of Inner Mongolia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects are eligible for inclusion in this study only if they meet all of the following criteria 1. 18-70 years old, gender unlimited ； 2. Previous history of gout ； 3. According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015； 4. 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 ： 1. Gout in the past two weeks ； 2. Secondary hyperuricemia ； 3. 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； 4. WBC \< 4.0 × 109 / L, PLT \< 100 × 109 / L, HGB \< 90g / L, or other hematological diseases ； 5. bad blood pressure control (BP\>160mmHg/100 mmHg) 6. Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ； 7. Patients with active peptic ulcer ； 8. Patients with gastrointestinal cancer ； 9. Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ； 10. 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 ； 11. Those who need continuous prednisone treatment ； 12. Those who need antibiotic treatment for infectious diseases ； 13. Those with body mass index (BMI) greater than 30 ； 14. people with alcoholism ； 15. People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ； 16. Researchers who have received other drugs within 3 months before screening ； 17. The people who are researchers thinks it is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum uric acid level | 24 weeks | 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 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum uric acid level at the 4、8、12、24 weeks | 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 |
| serum uric acid decreased from baseline | 4、8、12、24 weeks | At the end of 4, 8, 12 and 24 weeks after treatment, the serum uric acid level decreased from baseline |
| Acute attack of gout | 24 week | Number of acute gout attacks during 24 weeks of treatment |
Countries
China
Outcome results
None listed