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

Primary Purpose

Gout, Hyperuricemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotics
uric-acid-lowering drug
Sponsored by
The Affiliated Hospital of Inner Mongolia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring gout, hyperuricemia, probiotics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inner Mongolia Medical College Affiliated HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

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
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
Acute attack of gout
Number of acute gout attacks during 24 weeks of treatment

Full Information

First Posted
December 12, 2019
Last Updated
July 18, 2023
Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
Collaborators
Inner Mongolia Agricultural University, Inner Mongolia Hulunboir hospital, Inner Mongolia People's Hospital, Inner Mongolia Ordos Central Hospital, Inner Mongolia Baogang Hospital, Inner Mongolia Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04199325
Brief Title
Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial
Official Title
Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
Collaborators
Inner Mongolia Agricultural University, Inner Mongolia Hulunboir hospital, Inner Mongolia People's Hospital, Inner Mongolia Ordos Central Hospital, Inner Mongolia Baogang Hospital, Inner Mongolia Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
Keywords
gout, hyperuricemia, probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Intervention Type
Drug
Intervention Name(s)
uric-acid-lowering drug
Intervention Description
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
Primary Outcome Measure Information:
Title
serum uric acid level
Description
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 )
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
serum uric acid level at the 4、8、12、24 weeks
Description
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
Time Frame
4、8、12、24 weeks
Title
serum uric acid decreased from baseline
Description
At the end of 4, 8, 12 and 24 weeks after treatment, the serum uric acid level decreased from baseline
Time Frame
4、8、12、24 weeks
Title
Acute attack of gout
Description
Number of acute gout attacks during 24 weeks of treatment
Time Frame
24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Inner Mongolia Medical College Affiliated Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-bin LI, M.D
Phone
+86 13948536552
Email
lhbwb73@126.com

12. IPD Sharing Statement

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

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