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RecruitingNCT06981663Updated Aug 12, 2025

Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model

An observational study in Hyperuricemia, sponsored by Örebro University, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Örebro University, Sweden · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
15
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hyperuricemia

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Keywords

  • hyperuricemia
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hyperuricaemic adults

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

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
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
15 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

Secondary outcomes

  1. 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

    Time frame: 24 hours

  2. 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)

    Time frame: 24 hours

Other outcomes

  1. 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

    Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24h, supernatants will be analysed for general microbial activity (e.g., pH)

    Time frame: 24 hours

  2. 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

    Freshly collected faecal samples will be diluted and incubated with different beta-glucans and a probiotic product, and the faecal microbiome will be analysed in the pellets (by sequencing)

    Time frame: 24 hours

  3. 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

    Freshly collected faecal samples will be diluted and incubated with different beta-glucans and a probiotic product for 24h, pellets will be analysed regarding metagenetic activity (from transcriptomics)

    Time frame: 24 hours

  4. 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

    Freshly collected faecal samples will be diluted and incubated with different beta-glucans and two probiotic strains for 24h, pellets will be analysed regarding metagenetic activity (from metabolomics) using stool samples from hyperuricaemic individuals

    Time frame: 24 hours

  5. Combined data analysis to explore potential responders/non-responder characteristics to treatment with a probiotic product with or without beta-glucans

    Time frame: 24 hours

06

Study locations

1 of 1 sites recruiting
  • Örebro University
    Örebro, Sweden
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06981663
Lead sponsor
Örebro University, Sweden
Collaborators
University of Copenhagen
Responsible party
Julia König (PhD, Associate Professor, Örebro University, Sweden) — Principal investigator
First posted
May 21, 2025
Start date
Jun 12, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 12, 2025

Study contacts

Julia König, PhD
Contact
julia.konig@oru.se
0046 19 30 3645

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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