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

Not Applicable
Recruiting
Conditions
Hyperuricemia
Gout
Interventions
Dietary Supplement: Probiotics
Drug: uric-acid-lowering drug
Registration Number
NCT04199325
Lead Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupProbiotics-
Control groupuric-acid-lowering drug-
Intervention groupuric-acid-lowering drug-
Primary Outcome Measures
NameTimeMethod
serum uric acid level24 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 Outcome Measures
NameTimeMethod
Acute attack of gout24 week

Number of acute gout attacks during 24 weeks of treatment

serum uric acid decreased from baseline4、8、12、24 weeks

At the end of 4, 8, 12 and 24 weeks after treatment, the serum uric acid level decreased from baseline

serum uric acid level at the 4、8、12、24 weeks4、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

Trial Locations

Locations (1)

Inner Mongolia Medical College Affiliated Hospital

🇨🇳

Hohhot, Inner Mongolia, China

Inner Mongolia Medical College Affiliated Hospital
🇨🇳Hohhot, Inner Mongolia, China

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