The Effects of a Probiotic Food Supplement in Hyperuricaemia (Bugs4U-PoC)

Örebro University, Sweden

Status: Not yet enrolling

Conditions: Hyperuricemia With or Without Gout

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Probiotics plus fibre; Dietary Supplement: Placebo (no active ingredient)

Study type: Interventional

Funder types: Other

Identifiers

NCT07141888

2025-04358-01

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Recent (within last month) episode of gout
2. Diagnosis of type 1 diabetes
3. Diagnosed inflammatory bowel disease (IBD)
4. Current diagnosis of psychiatric disease/s or syndromes
5. Current diagnosis of neurodegenerative disease
6. Current pregnancy or breastfeeding
7. History of complicated gastrointestinal surgery
8. (Partial) resection of the small intestine or colon
9. Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion
10. Oral or intravenous administration of antibiotics and/or corticosteroids in the 4 months prior to inclusion
11. Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid)
12. Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion
13. Regular use of probiotic or prebiotic supplementation in the month prior to inclusion
14. Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Placebo - no active ingredients

Placebo Comparator group

Description:

No active ingredients

Treatment:

Dietary Supplement: Placebo (no active ingredient)

Probiotic product

Experimental group

Description:

Product contains two probiotic strains

Treatment:

Dietary Supplement: Probiotics

Probiotic product plus fibre

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics plus fibre