The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
| Registry | NCT07141888, acronym Bugs4U-PoC |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 99 (Estimated) |
| Sponsor | Örebro University, Sweden (Other) |
| Conditions | Hyperuricemia With or Without Gout |
| Interventions | Placebo (no active ingredient), Probiotics, Probiotics plus fibre (Dietary supplement) |
| Dates | start 2025-12-16, primary completion 2026-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-08-26, last updated 2026-03-27 |
| Locations | 1 site in Sweden |
Related Papers Related Patents Related Grants Related Experts
All trials for Hyperuricemia With or Without Gout All trials of Placebo (no active ingredient) All trials of Probiotics
The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid in the blood (hyperuricemia). Additionally, the project will investigate which individuals benefit from this dietary supplement and which do not, based on factors such as gut microbiota composition and function, dietary habits, genetic factors, and inflammatory status. The ultimate goal is to develop a personalized therapy for hyperuricemia.
At the beginning of the study, blood samples will be taken to determine uric acid levels and 99 individuals with hyperuricemia will be invited to participate in a 6-week intervention study with daily intake of dietary supplements. To examine the effect of the supplement on various health variables, blood, urine, stool, and breath samples will be collected on several occasions.
To better understand the underlying factors of hyperuricemia, questionnaire data and results from biological will be compared between participants with normal versus elevated uric acid levels. Furthermore, different outcome parameters from questionnaires and samples before and after supplement intake will be compared. In addition, various methods for estimating dietary intake will be investigated and compared with each other.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo - no active ingredients | Placebo comparator | Dietary Supplement: Placebo (no active ingredient) | No active ingredients |
| Probiotic product | Experimental | Dietary Supplement: Probiotics | Product contains two probiotic strains |
| Probiotic product plus fibre | Experimental | Dietary Supplement: Probiotics plus fibre | Product contains two probiotic strains and a fibre (beta-glucan) |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: 1. Signed informed consent prior to any study-related procedures 2. Age 18-80 years old 3. BMI range 17.5-40 kg/m2 4. Blood uric acid above 405 μmol/l (6.8 mg/dl) 5. Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) during the study 6. Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study Exclusion Criteria: 1. Recent (within last month) episode of gout 2. Diagnosis of type 1 diabetes 3. Diagnosed inflammatory bowel disease (IBD) 4. Current diagnosis of psychiatric disease/s or syndromes 5. Current diagnosis of neurodegenerative disease 6. Current pregnancy or breastfeeding 7. History of complicated gastrointestinal surgery 8. (Partial) resection of the small intestine or colon 9. Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion 10. Oral or intravenous administration of antibiotics and/or corticosteroids in the 4 months prior to inclusion 11. Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid) 12. Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion 13. Regular use of probiotic or prebiotic supplementation in the month prior to inclusion 14. Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
| Facility | City | Country | Status |
|---|---|---|---|
| Örebro University | Örebro | Sweden | Recruiting |
NIH grants: 2025