Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial
NCT ID: NCT04199325
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2018-11-01
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
Probiotics
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
uric-acid-lowering drug
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Control group
uric-acid-lowering drug
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Interventions
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Probiotics
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
uric-acid-lowering drug
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Eligibility Criteria
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Inclusion 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Inner Mongolia University of Science and Technology
OTHER
Inner Mongolia Hulunboir hospital
UNKNOWN
Inner Mongolia People's Hospital
OTHER
Inner Mongolia Ordos Central Hospital
UNKNOWN
Inner Mongolia Baogang Hospital
OTHER
Inner Mongolia Medical College
UNKNOWN
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
Responsible Party
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Locations
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Inner Mongolia Medical College Affiliated Hospital
Hohhot, Inner Mongolia, China
Countries
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Facility Contacts
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Other Identifiers
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