HyperuricemiaNCT06981663
Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model
An observational study of Hyperuricemia, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperuricemia
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 12 Jun 2025to Dec 2028
- Phase
- Observational
- 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
Study population: Hyperuricaemic adults
Who may be able to join
- Signed informed consent prior to any study-related procedures
- Age 18-80 years old
- BMI range 18.5-35 kg/m2
- Blood uric acid above 0.36 mmol/L (6 mg/dl)
- Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages), until collection of faecal material
- Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study, until collection of faecal material
Who cannot join
- Diagnosis of type 1 and/or type 2 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
Show all 12Show fewer
- Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
- Regular use of any non-steroidal anti-inflammatory drug (NSAID) for the last 2 months
- Consumption of any NSAID within 3 days of sample collection
- Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
- Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
- After being included in the study and until collection of faecal material, starting any medication or treatment that could potentially influence the study participation and/or study analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model
In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.
Read the detailed description
In this study, the investigators will collect blood samples to check if recruited participants have hyperuricemia, and if yes, stool samples will be collected for laboratory faecal fermentation tests. The research project aims to investigate the effects of probiotics and dietary fibers on stool samples, to understand if and how they can support the gut microbiota to break down uric acid in the gut.
Participation in the study involves data collection and sampling on three occasions. During the first visit, participants will provide a blood sample, and if they have increased urate levels, they will be asked to complete questionnaires and be provided with materials for stool sampling during the second visit. During the third visit, they will provide the stool sample, which will then be used in the faecal fermentation experiments, where different fibres (beta-glucans) will be tested in combination with probiotics.
- Conditions
- Hyperuricemia
- Keywords
- hyperuricemia
- Medical subject headings
- Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of three different beta-glucans in combination with two probiotic strains on urate levels in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24 hours, supernatants will be analysed for urate levels
Measured: 24 hours
Secondary outcomes (2)
Effect of three different beta-glucans in combination with two probiotic strains on upstream and downstream metabolites of urate in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24 hours, supernatants will be analysed for urate levels
Measured: 24 hours
Effect of three different beta-glucans in combination with two probiotic strains on on short-chain fatty acids (SCFA) in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24h, supernatants will be analysed for short-chain fatty acids (SCFA)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Julia König, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981663
- Sponsor's protocol ID
- 2025-01926-01
- Other IDs
- 2025-01926-01, 2025
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model
- ClinicalTrials.gov ID
- NCT06981663
- Acronym / sponsor ID
- 2025-01926-01
- Conditions
- Hyperuricemia
- Keywords
- hyperuricemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 May 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.
In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.
Detailed description
In this study, the investigators will collect blood samples to check if recruited participants have hyperuricemia, and if yes, stool samples will be collected for laboratory faecal fermentation tests. The research project aims to investigate the effects of probiotics and dietary fibers on stool samples, to understand if and how they can support the gut microbiota to break down uric acid in the gut.
Participation in the study involves data collection and sampling on three occasions. During the first visit, participants will provide a blood sample, and if they have increased urate levels, they will be asked to complete questionnaires and be provided with materials for stool sampling during the second visit. During the third visit, they will provide the stool sample, which will then be used in the faecal fermentation experiments, where different fibres (beta-glucans) will be tested in combination with probiotics.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperuricaemic adults
Key inclusion criteria (6 listed)
- Signed informed consent prior to any study-related procedures
- Age 18-80 years old
- BMI range 18.5-35 kg/m2
- Blood uric acid above 0.36 mmol/L (6 mg/dl)
- Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages), until collection of faecal material
Key exclusion criteria (12 listed)
- Diagnosis of type 1 and/or type 2 diabetes
- Diagnosed inflammatory bowel disease (IBD)
- Current diagnosis of psychiatric disease/s or syndromes
- Current diagnosis of neurodegenerative disease
- Current pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of three different beta-glucans in combination with two probiotic strains on urate levels in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Time frame: 24 hours
Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24 hours, supernatants will be analysed for urate levels
2 secondary outcomes
Effect of three different beta-glucans in combination with two probiotic strains on upstream and downstream metabolites of urate in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Time frame: 24 hours
Effect of three different beta-glucans in combination with two probiotic strains on on short-chain fatty acids (SCFA) in faecal fermentation supernatants using stool samples from hyperuricaemic individuals
Time frame: 24 hours
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Hyperuricemia, 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 12 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 12 Aug 2025. 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. 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?
Contact Julia König, PhD (0046 19 30 3645, julia.konig@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of three different beta-glucans in combination with two probiotic strains on urate levels in faecal fermentation supernatants using stool samples from hyperuricaemic individuals (time frame: 24 hours). 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 12 Aug 2025.