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

Sponsor

The Affiliated Hospital of Inner Mongolia Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04199325

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout Hyperuricemia	Dietary Supplement: Probiotics Drug: uric-acid-lowering drug	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group	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.
Placebo Comparator: Control group	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.

Arm

Intervention/Treatment

Experimental: Intervention group

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.

Placebo Comparator: Control group

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects are eligible for inclusion in this study only if they meet all of the following criteria

18-70 years old, gender unlimited ；
Previous history of gout ；
According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
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 ：

Gout in the past two weeks ；
Secondary hyperuricemia ；
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；
WBC < 4.0 × 109 / L, PLT < 100 × 109 / L, HGB < 90g / L, or other hematological diseases ；
bad blood pressure control (BP>160mmHg/100 mmHg)
Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
Patients with active peptic ulcer ；
Patients with gastrointestinal cancer ；
Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
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 ；
Those who need continuous prednisone treatment ；
Those who need antibiotic treatment for infectious diseases ；
Those with body mass index (BMI) greater than 30 ；
people with alcoholism ；
People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ；
Researchers who have received other drugs within 3 months before screening ；
The people who are researchers thinks it is not suitable to participate in the study.