- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04199325
Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial
July 18, 2023 updated by: The Affiliated Hospital of Inner Mongolia Medical University
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
Intervention / Treatment
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:
- Hong-bin LI, M.D
- Phone Number: +86 13948536552
- Email: lhbwb73@126.com
-
-
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
- 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.
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Metabolism, Inborn Errors
- Crystal Arthropathies
- Purine-Pyrimidine Metabolism, Inborn Errors
- Hyperuricemia
- Gout
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Uric Acid
Other Study ID Numbers
- qpfff@126.com
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
-
Lingling Yu (103250)Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Xianning...Recruiting
-
Sun Yat-sen UniversityRecruiting
-
China Medical University HospitalUnknownHyperuricemia, Anserine, PharmacokineticTaiwan
-
Shanghai Institute Of Biological ProductsFirst Affiliated Hospital Bengbu Medical CollegeCompletedAsymptomatic HyperuricemiaChina
-
China Medical University HospitalUnknown"Hyperuricemia,Anserine"Taiwan
-
AstraZenecaContract Research Organization: USA; PAREXEL Early Phase Clinical Unit Baltimore and other collaboratorsCompletedAsymptomatic HyperuricemiaUnited States
-
University of MinnesotaCompleted
-
Hebei Medical UniversityCompletedHeart Failure, HyperuricemiaChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
Clinical Trials on Probiotics
-
Glac Biotech Co., LtdCompletedMetabolic SyndromeTaiwan
-
TCI Co., Ltd.Recruiting
-
University of Milano BicoccaCompleted
-
Arkansas Children's Hospital Research InstituteCompleted
-
Chr HansenAarhus University HospitalCompletedInfant Development | Gut MicrobiomeDenmark
-
Zealand University HospitalHolbaek Sygehus; Chr Hansen; Dept. of Microbiology, Slagelse University Hospital... and other collaboratorsCompleted
-
National Cheng-Kung University HospitalNational Science Council, TaiwanUnknownGastrointestinal Function | Intestinal Bacteria FloraTaiwan
-
Chung Shan Medical UniversityTCI Co., Ltd.Recruiting
-
Prof. Jacques SCHRENZELCompleted
-
Glac Biotech Co., LtdCompletedProbiotics | Oral Health | Probiotic MetabolitesTaiwan