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

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-12
• Study Completion: 2024-03

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

Group	Intervention	Description
Intervention group	Probiotics	-
Control group	uric-acid-lowering drug	-
Intervention group	uric-acid-lowering drug	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acute attack of gout	24 week	Number of acute gout attacks during 24 weeks of 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
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

Trial Locations

Locations (1)

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