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Recruiting NCT06981663

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

Observational Hyperuricemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hyperuricemia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Sweden · 1 center
  • Örebro University — Örebro

Identifiers

NCT: NCT06981663 · 2025-01926-01 · 2025-01926-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗