The Effects of a Probiotic Food Supplement in Hyperuricaemia

NCT07141888 | Recruiting

• 1 other identifier: 2025-04358-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid in the blood (hyperuricemia). Additionally, the project will investigate which individuals benefit from this dietary supplement and which do not, based on factors such as gut microbiota composition and function, dietary habits, genetic factors, and inflammatory status. The ultimate goal is to develop a personalized therapy for hyperuricemia. At the beginning of the study, blood samples will be taken to determine uric acid levels and 99 individuals with hyperuricemia will be invited to participate in a 6-week intervention study with daily intake of dietary supplements. To examine the effect of the supplement on various health variables, blood, urine, stool, and breath samples will be collected on several occasions. To better understand the underlying factors of hyperuricemia, questionnaire data and results from biological will be compared between participants with normal versus elevated uric acid levels. Furthermore, different outcome parameters from questionnaires and samples before and after supplement intake will be compared. In addition, various methods for estimating dietary intake will be investigated and compared with each other.

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (1)

• Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo

  Baseline-corrected blood urate levels in the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm

  6 weeks

Secondary Outcomes (51)

• Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo

  3 weeks

• Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo

  3 weeks

• Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo

  6 weeks

• Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo

  3 weeks

• Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo

  6 weeks

Study Arms (3)

Placebo - no active ingredients

PLACEBO COMPARATOR

No active ingredients

Dietary Supplement: Placebo (no active ingredient)

Probiotic product

EXPERIMENTAL

Product contains two probiotic strains

Dietary Supplement: Probiotics

Probiotic product plus fibre

EXPERIMENTAL

Product contains two probiotic strains and a fibre (beta-glucan)

Dietary Supplement: Probiotics plus fibre

Interventions

Placebo (no active ingredient) DIETARY_SUPPLEMENT

Placebo product containing the same ingredients as the active intervention but without the active compounds

Placebo - no active ingredients

Probiotics DIETARY_SUPPLEMENT

Product contains two probiotic strains

Probiotic product

Probiotics plus fibre DIETARY_SUPPLEMENT

Product contains two probiotic strains plus a fibre (beta-glucan)

Probiotic product plus fibre

Eligibility Criteria

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

You may qualify if:

• Signed informed consent prior to any study-related procedures
• Age 18-80 years old
• BMI range 17.5-40 kg/m2
• Blood uric acid above 405 μmol/l (6.8 mg/dl)
• Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) during the study
• Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study

You may not qualify if:

• Recent (within last month) episode of gout
• Diagnosis of type 1 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
• (Partial) resection of the small intestine or colon
• Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion
• Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Sweden

RECRUITING

MeSH Terms

Interventions

Probiotics; Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, PhD

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 26, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

SE (1)