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

NCT06981663 | Recruiting

• 1 other identifier: 2025-01926-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia

Keywords

hyperuricemia

Outcome Measures

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

  24 hours

Secondary Outcomes (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

  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

  24 hours

Other Outcomes (5)

• 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

  24 hours

• 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

  24 hours

• 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

  24 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hyperuricaemic adults

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• University of Copenhagen: collaborator

Study Sites (1)

Örebro University

Örebro, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Julia König, PhD

CONTACT

0046 19 30 3645; julia.konig@oru.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 21, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)