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Идёт набор NCT06981663

Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model

— Наблюдательное Hyperuricemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hyperuricemia. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model

Обзор

In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.

Подробное описание

In this study, the investigators will collect blood samples to check if recruited participants have hyperuricemia, and if yes, stool samples will be collected for laboratory faecal fermentation tests. The research project aims to investigate the effects of probiotics and dietary fibers on stool samples, to understand if and how they can support the gut microbiota to break down uric acid in the gut.

Participation in the study involves data collection and sampling on three occasions. During the first visit, participants will provide a blood sample, and if they have increased urate levels, they will be asked to complete questionnaires and be provided with materials for stool sampling during the second visit. During the third visit, they will provide the stool sample, which will then be used in the faecal fermentation experiments, where different fibres (beta-glucans) will be tested in combination with probiotics.

Первичные конечные точки

  • Effect of three different beta-glucans in combination with two probiotic strains on urate levels in faecal fermentation supernatants using stool samples from hyperuricaemic individuals [Срок оценки: 24 hours]
Вторичные конечные точки (2)
  • Effect of three different beta-glucans in combination with two probiotic strains on upstream and downstream metabolites of urate in faecal fermentation supernatants using stool samples from hyperuricaemic individuals [Срок оценки: 24 hours]
  • Effect of three different beta-glucans in combination with two probiotic strains on on short-chain fatty acids (SCFA) in faecal fermentation supernatants using stool samples from hyperuricaemic individuals [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Signed informed consent prior to any study-related procedures
  • Age 18-80 years old
  • BMI range 18.5-35 kg/m2
  • Blood uric acid above 0.36 mmol/L (6 mg/dl)
  • Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages), until collection of faecal material
  • Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study, until collection of faecal material

Критерии исключения

  • Diagnosis of type 1 and/or type 2 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
  • Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
  • Regular use of any non-steroidal anti-inflammatory drug (NSAID) for the last 2 months
  • Consumption of any NSAID within 3 days of sample collection
  • Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
  • Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
  • After being included in the study and until collection of faecal material, starting any medication or treatment that could potentially influence the study participation and/or study analysis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Швеция · 1 центр
  • Örebro University — Örebro

Идентификаторы

NCT: NCT06981663 · 2025-01926-01 · 2025-01926-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗