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

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010000
        • Recruiting
        • Inner Mongolia Medical College Affiliated Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
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
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum uric acid level
Time Frame: 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 )
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum uric acid level at the 4、8、12、24 weeks
Time Frame: 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
serum uric acid decreased from baseline
Time Frame: 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
4、8、12、24 weeks
Acute attack of gout
Time Frame: 24 week
Number of acute gout attacks during 24 weeks of treatment
24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperuricemia

Clinical Trials on Probiotics

3
Subscribe