Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06981663

Effects of Fibres Combined With Probiotics on Uric Acid 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro University

Örebro, Sweden

Location status: Recruiting

About this study

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.

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 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

    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

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

    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. 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

    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)

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

    Time frame: 24 hours

    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)

  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

    Time frame: 24 hours

    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)

  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

    Time frame: 24 hours

    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)

  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

    Time frame: 24 hours

    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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Julia König, PhD

CONTACT

[email protected]

0046 19 30 3645

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 21, 2025
Registry last updated
Aug 12, 2025

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.

Published trials that share one or more normalized conditions with this study.