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

Launched by THE AFFILIATED HOSPITAL OF INNER MONGOLIA MEDICAL UNIVERSITY · Dec 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a probiotic called Lactobacillus Zhang in combination with standard treatments for gout and high uric acid levels (known as hyperuricemia). The goal is to see if this probiotic can help improve symptoms and safety for patients who have a history of gout and elevated uric acid levels.

To participate in this study, individuals need to be between 18 and 70 years old, have a history of gout, and have a fasting serum uric acid level of at least 480 µmol/L (which is about 8 mg/dL). However, there are several criteria that could exclude someone from participating, such as recent gout attacks, certain health conditions (like liver or kidney problems), or if they are currently taking specific medications that affect uric acid levels. If eligible, participants can expect to be part of a double-blind study, meaning neither they nor the researchers will know who is receiving the probiotic or a placebo, ensuring the results are unbiased. This trial is currently recruiting participants, and it’s an opportunity to contribute to research that could help improve treatment options for gout in the future.

Gender

ALL

Eligibility criteria

• 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.