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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199325
• Other study ID #: qpfff@126.com
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: The Affiliated Hospital of Inner Mongolia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Dietary Supplement:
• Probiotics
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

Drug:
• 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.

Locations

Country	Name	City	State
China	Inner Mongolia Medical College Affiliated Hospital	Hohhot	Inner Mongolia

Sponsors (7)

Lead Sponsor	Collaborator
The Affiliated Hospital of Inner Mongolia Medical University	Inner Mongolia Agricultural University, Inner Mongolia Baogang Hospital, Inner Mongolia Hulunboir hospital, Inner Mongolia Medical College, Inner Mongolia Ordos Central Hospital, Inner Mongolia People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Acute attack of gout	Number of acute gout attacks during 24 weeks of treatment	24 week