Clinical trial NCT06981663: Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model
Official title: Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hyperuricemia
Keywords: hyperuricemia
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2025-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hyperuricaemic adults

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to any study-related procedures
2. Age 18-80 years old
3. BMI range 18.5-35 kg/m2
4. Blood uric acid above 0.36 mmol/L (6 mg/dl)
5. 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
6. 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

Exclusion Criteria:

1. Diagnosis of type 1 and/or type 2 diabetes
2. Diagnosed inflammatory bowel disease (IBD)
3. Current diagnosis of psychiatric disease/s or syndromes
4. Current diagnosis of neurodegenerative disease
5. Current pregnancy or breastfeeding
6. History of complicated gastrointestinal surgery
7. Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
8. Regular use of any non-steroidal anti-inflammatory drug (NSAID) for the last 2 months
9. Consumption of any NSAID within 3 days of sample collection
10. Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
11. Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
12. 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

Primary outcomes:
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
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: 24 hours
measure: 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
timeFrame: 24 hours
Other outcomes:
measure: Effect of three different beta-glucans in combination with two probiotic strains on general microbial activity (e.g., pH) of the faecal fermentation extracts using stool samples from hyperuricaemic individuals
timeFrame: 24 hours
measure: Effect of three different beta-glucans in combination with two probiotic strains on the faecal microbiome of the faecal fermentation extracts using stool samples from hyperuricaemic individuals
timeFrame: 24 hours
measure: Effect of three different beta-glucans in combination with two probiotic strains on the metagenetic activity (using transcriptomics) of the faecal fermentation extracts using stool samples from hyperuricaemic individuals
timeFrame: 24 hours
measure: Effect of three different beta-glucans in combination with two probiotic strains on the metagenetic activity (using metabolomics) of the faecal fermentation extracts using stool samples from hyperuricaemic individuals
timeFrame: 24 hours
measure: Combined data analysis to explore potential responders/non-responder characteristics to treatment with a probiotic product with or without beta-glucans
timeFrame: 24 hours
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References: