Örebro University
Örebro, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT07141888
The Effects of a Probiotic Food Supplement in Hyperuricaemia
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Signed informed consent prior to any study-related procedures
- Age 18-80 years old
- BMI range 17.5-40 kg/m2
- Blood uric acid above 405 μmol/l (6.8 mg/dl)
- Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) during the study
- Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
Exclusion criteria
- Recent (within last month) episode of gout
- Diagnosis of type 1 diabetes
- Diagnosed inflammatory bowel disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
- Current diagnosis of neurodegenerative disease
- Current pregnancy or breastfeeding
- History of complicated gastrointestinal surgery
- (Partial) resection of the small intestine or colon
- Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion
- Oral or intravenous administration of antibiotics and/or corticosteroids in the 4 months prior to inclusion
- Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid)
- Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion
- Regular use of probiotic or prebiotic supplementation in the month prior to inclusion
- Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
Treatment and study plan
Placebo (no active ingredient)
Dietary SupplementPlacebo product containing the same ingredients as the active intervention but without the active compounds
Probiotics
Dietary SupplementProduct contains two probiotic strains
Probiotics plus fibre
Dietary SupplementProduct contains two probiotic strains plus a fibre (beta-glucan)
Primary outcomes
-
Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate levels in the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm
Secondary outcomes
-
Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood urate levels in the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood urate levels in the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate levels in the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood urate-related metabolite levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate-related metabolite levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood urate-related metabolite levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate-related metabolite levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood urate-related enzyme levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate-related enzyme levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate-related enzyme levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood urate-related enzyme levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related metabolite levels in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related metabolite levels in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related metabolite levels in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related metabolite levels in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related enzyme levels in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related enzymes levels in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related enzyme levels in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related enzyme levels in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related enzymes levels in urine samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related enzymes levels in urine samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related enzymes levels in urine samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related enzymes levels in urine samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected inflammation markers in blood samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected inflammation markers in blood samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected inflammation markers in blood samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected inflammation markers in blood samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected inflammation markers in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected inflammation markers in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected inflammation markers in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected inflammation markers in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urine creatinine levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urine creatinine levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate levels in stool samples of the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate levels in stool samples of the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate levels in stool of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate levels in stool samples of the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate levels in stool of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate levels in stool samples of the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate levels in urine samples of the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate levels in urine samples of the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate levels in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate levels in urine samples of the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate levels in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate levels in urine samples of the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related metabolite levels in urine samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related metabolite levels in urine samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
-
Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Baseline-corrected urate-related metabolite levels in urine samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
-
Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
Baseline-corrected urate-related metabolite levels in urine samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
Sponsors and collaborators
Lead sponsor
Örebro University, Sweden
Other
Registry information
Official study title
The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
Acronym: Bugs4U-PoC
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Aug 26, 2025
- Registry last updated
- Mar 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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