The Effects of a Probiotic Food Supplement in Hyperuricaemia

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Placebo (no active ingredient)
  Placebo product containing the same ingredients as the active intervention but without the active compounds
• Пищевая добавка Probiotics
  Product contains two probiotic strains
• Пищевая добавка Probiotics plus fibre
  Product contains two probiotic strains plus a fibre (beta-glucan)

Первичные конечные точки

• Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 6 weeks]
• Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo [Срок оценки: 3 weeks]
• Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]
• Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo [Срок оценки: 3 weeks]
• Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]
• Effect of a 3-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo [Срок оценки: 3 weeks]
• Effect of a 6-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]
• Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]
• Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo [Срок оценки: 6 weeks]
• Effect of a 3-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion
• Oral or intravenous administration of antibiotics and/or corticosteroids in the 4 months prior to inclusion
• Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid)
• Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion
• Regular use of probiotic or prebiotic supplementation in the month prior to inclusion
• Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Örebro University — Örebro

Идентификаторы

NCT: NCT07141888 · 2025-04358-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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