Beta-Hydroxybutyrate Feasibility Treating IBD
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
- В протоколе указаны: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's.
- Кому может быть актуально
- Состояния в реестре: Crohn's Disease, Inflammatory Bowel Diseases. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
Обзор
This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease. The main questions it aims to answer are: * BHB supplementation will be feasible and acceptable to patients. * BHB supplementation will be associated with a reduction in systemic inflammation. * BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies. Participants will: * Take 3 capsules x 3 times per day for 4 weeks. * Document food consumption using a 24-hour food recall questionnaire. * Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark. Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.
Подробное описание
A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate (BHB) in Crohn's patients in a prospective, open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome, inflammation, and markers of disease severity in Crohn's patients in a prospective pre-/post-study design.
Вмешательства
- Биопрепарат Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.
Первичные конечные точки
- Ability to enroll patients who meet the inclusion criteria within the target time frame [Срок оценки: 12 months]
- Adherence to proposed study timelines and anticipated study costs [Срок оценки: 12 months]
- Patient adherence to the intervention [Срок оценки: 12 months]
Вторичные конечные точки (8)
- Microbial Diversity [Срок оценки: 4 weeks]
- BHB Blood Levels [Срок оценки: 4 weeks]
- Gastrointestinal Symptoms [Срок оценки: 4 weeks]
- Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS) [Срок оценки: 4 weeks]
- Clinical Response [Срок оценки: 4 weeks]
- Systemic Inflammation [Срок оценки: 4 weeks]
- Adverse Events [Срок оценки: 4 weeks]
- Assess disease activity by Intestinal Ultrasound (IUS) [Срок оценки: 4 weeks]
Критерии участия
Критерии включения
- Age ≥18 years of age
- Confirmed diagnosis of Crohn's disease
- Active disease defined as either a fecal calprotectin \>250 µg/g or active disease on endoscopy within the prior 3 months
- Starting a new therapy defined as a biologic (anti-TNF, anti-integrin, IL-12/23, or IL-23) or small molecule therapy (JAK inhibitor, S1P receptor modulator)
- Willing to provide consent for participation.
- Managed at UT Digestive Health Clinic.
Критерии исключения
- Any current or recent (within 4 weeks) use of BHB supplement
- Currently or recently (within 4 weeks) following a ketogenic diet
- Currently or recently (within 4 weeks) following an intermittent fasting diet
- Any recent antibiotic use (within 3 months)
- Recent infection with C. difficile (within 6 months)
- Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)
- Current or recent use (within four weeks) of non-dietary probiotic supplements
- Unwilling to provide signed consent
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- University of Texas at Austin — Austin
Идентификаторы
NCT: NCT06351124 · 00005294