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

Last updated: August 11, 2025
Sponsor: Örebro University, Sweden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gout (Hyperuricemia)

Treatment

N/A

Clinical Study ID

NCT06981663
2025-01926-01
2025-01926-01
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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 foodproducts 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 toalter gastrointestinal function or inflammatory status during the study, untilcollection of faecal material

Exclusion

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 toinclusion

  8. Regular use of any non-steroidal anti-inflammatory drug (NSAID) for the last 2months

  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 probioticsupplementation

  11. Any condition or intake of medication which could substantially interfere with theoutcome of the study, as decided by the principal investigator's discretion

  12. After being included in the study and until collection of faecal material, startingany medication or treatment that could potentially influence the study participationand/or study analysis

Study Design

Total Participants: 15
Study Start date:
June 12, 2025
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Örebro University

    Örebro,
    Sweden

    Active - Recruiting

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