Last updated: July 18, 2023
Sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Gout (Hyperuricemia)
Arthritis And Arthritic Pain (Pediatric)
Joint Injuries
Treatment
uric-acid-lowering drug
Probiotics
Clinical Study ID
NCT04199325
qpfff@126.com
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects are eligible for inclusion in this study only if they meet all of the followingcriteria
- 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
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 thanthe 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 hematologicaldiseases ;
- 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, irritablebowel syndrome, inflammatory bowel disease and habitual diarrhea ;
- Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannotbe 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 highsensitive 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 Design
Total Participants: 300
Treatment Group(s): 2
Primary Treatment: uric-acid-lowering drug
Phase:
Study Start date:
November 01, 2018
Estimated Completion Date:
March 31, 2024
Connect with a study center
Inner Mongolia Medical College Affiliated Hospital
Hohhot, Inner Mongolia 010000
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.