Daily probiotic supplement for adults with high uric acid
The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
This will see if taking a daily probiotic, with or without added fiber, lowers blood uric acid in adults with high uric acid (with or without gout).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Örebro University, Sweden Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT07141888 on ClinicalTrials.gov |
What this trial studies
Ninety-nine adults with elevated blood uric acid will be enrolled in a 6-week randomized intervention comparing placebo, a probiotic supplement, and a probiotic plus fiber supplement. Blood, urine, stool, and breath samples will be collected at multiple visits to measure uric acid and other biological markers. The study will also analyze participants' gut microbiota, dietary habits, genetics, and inflammatory status to identify who benefits most. The ultimate aim is to use these data to inform a more personalized dietary supplement approach for managing hyperuricemia.
Who should consider this trial
Good fit: Adults aged 18–80 with blood uric acid above 405 μmol/L (6.8 mg/dL), BMI 17.5–40 kg/m2, and willingness to avoid other probiotic foods and certain supplements during the 6-week study.
Not a fit: People with a recent gout attack, type 1 diabetes, inflammatory bowel disease, major bowel resections, current pregnancy or breastfeeding, or those taking excluded urate-lowering drugs are not eligible and would not benefit from participating.
Why it matters
Potential benefit: If successful, this could provide a simple, non-drug dietary option to lower uric acid and help personalize treatment for people with hyperuricemia or gout.
How similar studies have performed: Some small human and animal studies have suggested certain probiotics can modestly lower uric acid, but the approach remains relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Örebro
- Örebro University — Örebro, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.