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

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects are eligible for inclusion in this study only if they meet all of the followingcriteria

  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

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 thanthe 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 hematologicaldiseases ;
  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, irritablebowel syndrome, inflammatory bowel disease and habitual diarrhea ;
  10. 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 ;
  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 highsensitive 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 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
    China

    Active - Recruiting

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