Clinical Research Directory

Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia

This single-center, open-label, two-arm interventional study aims to evaluate the efficacy and safety of a probiotic-uricase complex preparation in patients with hyperuricemia. Participants aged 18 to 60 years with hyperuricemia will be assigned to either the intervention group or the control group. Participants in the intervention group will receive the probiotic-uricase complex preparation during a 2-week treatment period according to the study protocol in addition to conventional management, while participants in the control group will receive conventional management alone. Blood, urine, and fecal samples will be collected at baseline and during follow-up. The primary goal is to assess the change in serum uric acid from baseline after treatment. Secondary assessments include changes in uric acid-related metabolites in blood, urine, and feces, alterations in gut microbiota composition based on metagenomic analysis, and safety outcomes including laboratory parameters and adverse events. This study will explore whether the probiotic-uricase complex may serve as a safe and effective oral intervention for improving uric acid metabolism in patients with hyperuricemia.

Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects

This is a pilot study investigating how a novel probiotic supplement (BEO001), with and without a dietary fiber (beta-glucan), affects the lining of the small intestine in healthy people. The main goal is to see if a single dose of the probiotic changes gene activity (transcriptomics) and sugar molecule patterns (glycomics) in the gut. Eight participants will take three different treatments (placebo, probiotic alone, probiotic with fiber) in a random order, with at least 10 days between each. A gastroscopy to collect small intestinal tissue samples (biopsies) is performed the morning after each treatment. Blood and breath samples are also collected at these visits to explore effects on metabolism and inflammation. To understand how different sampling methods compare, participants collect stool samples and simple rectal swabs at home before any treatment. Researchers analyze the sugar molecules and bacteria in these samples, then compare them to each other and to the gut tissue samples collected after treatment. This helps determine if easier-to-collect samples can provide similar information to gut biopsies. The study also aims to combine all data (including genetics and diet) to identify key targets for future research and to attempt to grow 'mini-gut' organoids from the biopsies. The results will help design larger future studies in people with high uric acid levels.

Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

The aim of this study is to investigate the relationship between body fat distribution measured by CT scan and related risk factors with the risk of incident metabolic and cardiovascular disease in a prospective cohort study of Japanese men and women. The investigators will also investigate novel risk factors for metabolic and cardiovascular disease using molecular weight-based metallomics analysis.