Hyperuricemia With or Without GoutBugs4U-PoCNCT07141888
The Effects of a Probiotic Food Supplement in Hyperuricaemia
A study testing Probiotics and Probiotics plus fibre in people with Hyperuricemia With or Without Gout, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperuricemia With or Without Gout
- What is being tested?
- Probiotics and Probiotics plus fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteSweden
- Study dates
- 16 Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Örebro University
Örebro
Julia König, b4u@oru.se
About this study
Official title: The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
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.
- Conditions
- Hyperuricemia With or Without Gout
- Being tested
- Placebo (no active ingredient), Probiotics, Probiotics plus fibre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (no active ingredient)Dietary supplement
Placebo product containing the same ingredients as the active intervention but without the active compounds
ProbioticsDietary supplement
Product contains two probiotic strains
Probiotics plus fibreDietary supplement
Product contains two probiotic strains plus a fibre (beta-glucan)
| Study group | Role | What they receive |
|---|---|---|
| Placebo - no active ingredients | Placebo comparator | No active ingredients Receives: Dietary Supplement: Placebo (no active ingredient) |
| Probiotic product | Experimental | Product contains two probiotic strains Receives: Dietary Supplement: Probiotics |
| Probiotic product plus fibre | Experimental | Product contains two probiotic strains and a fibre (beta-glucan) Receives: Dietary Supplement: Probiotics plus fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate levels in the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
Secondary outcomes (51)
Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate levels in the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate-related metabolite levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate-related metabolite levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate-related enzyme levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo
Baseline-corrected blood urate-related enzyme levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
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
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
Measured: 6 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Baseline-corrected inflammation markers in blood samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo
Baseline-corrected inflammation markers in blood samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Baseline-corrected inflammation markers in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo
Baseline-corrected inflammation markers in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Baseline-corrected urine creatinine levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Baseline-corrected urine creatinine levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
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
Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm
Measured: 3 weeks
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
Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Effect of a 3-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
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
Measured: 3 weeks
Effect of a 6-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo
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
Measured: 6 weeks
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
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
Measured: 3 weeks
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
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start16 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia With or Without GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia König, PhD, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141888
- Sponsor's protocol ID
- 2025-04358-01
- Other IDs
- 2025
- Acronym
- Bugs4U-PoC
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to Swedish ethics regulations, IPD cannot be shared without an approved ethics application from the National Swedish Ethics Authority. An ethical permit can only be obtained for research being conducted within Sweden.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
- ClinicalTrials.gov ID
- NCT07141888
- Acronym / sponsor ID
- Bugs4U-PoC / 2025-04358-01
- Conditions
- Hyperuricemia With or Without Gout
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo - no active ingredients | Placebo comparator | Dietary Supplement: Placebo (no active ingredient)No active ingredients |
| Probiotic product | Experimental | Dietary Supplement: ProbioticsProduct contains two probiotic strains |
| Probiotic product plus fibre | Experimental | Dietary Supplement: Probiotics plus fibreProduct contains two probiotic strains and a fibre (beta-glucan) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (no active ingredient)Placebo product containing the same ingredients as the active intervention but without the active compounds | Dietary supplement | Placebo - no active ingredients |
| ProbioticsProduct contains two probiotic strains | Dietary supplement | Probiotic product |
| Probiotics plus fibreProduct contains two probiotic strains plus a fibre (beta-glucan) | Dietary supplement | Probiotic product plus fibre |
Primary outcome
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
51 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Effect of a 3-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Effect of a 6-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
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
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
Effect of a 3-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 3 weeks
Effect of a 6-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo
Time frame: 6 weeks
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. According to Swedish ethics regulations, IPD cannot be shared without an approved ethics application from the National Swedish Ethics Authority. An ethical permit can only be obtained for research being conducted within Sweden.
Related trials for Hyperuricemia With or Without Gout
Active, not recruitingPhase 1
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
Hyperuricemia With or Without Gout
Recruiting
Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia
Hyperuricemia With or Without Gout
Enrolling by invitationPhase 1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
Hyperuricemia With or Without Gout
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and Probiotics plus fibre in people with Hyperuricemia With or Without Gout, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.