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The Effects of a Probiotic Food Supplement in Hyperuricaemia

ConditionHyperuricemia With or Without Gout
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorÖrebro University, Sweden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo (no active ingredient)

    Dietary supplement

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

  • Probiotics

    Dietary supplement

    Product contains two probiotic strains

  • Probiotics plus fibre

    Dietary supplement

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

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Placebo - no active ingredientsPlacebo comparator 1 intervention
Group B: Probiotic productExperimental treatment 1 intervention
Group C: Probiotic product plus fibreExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 weeks

Secondary outcomes

1

Effect of a 3-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 three weeks will be compared to the levels in the placebo arm

Time frame
3 weeks
2

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

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

Time frame
3 weeks
3

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

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

Time frame
6 weeks
4

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

Baseline-corrected blood urate-related metabolite levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Örebro University, Sweden

Lead sponsor

Source ClinicalTrials.gov
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