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The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Örebro University
RECRUITING
Örebro
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2027-12
Participants
Target number of participants: 99
Treatments
Placebo_comparator: Placebo - no active ingredients
No active ingredients
Experimental: Probiotic product
Product contains two probiotic strains
Experimental: Probiotic product plus fibre
Product contains two probiotic strains and a fibre (beta-glucan)
Related Therapeutic Areas
Sponsors
Leads: Örebro University, Sweden

This content was sourced from clinicaltrials.gov

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