Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adherence to proposed study timelines and anticipated study costs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard of care therapy plus BHB supplementation (intervention).
Arm does receives the BHB supplement
干预措施: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's (Biological)
结局指标
主要结局
Adherence to proposed study timelines and anticipated study costs
时间窗: 12 months
Alignment of predicted timeline and costs to real timeline and costs
Patient adherence to the intervention
时间窗: 12 months
How many dosages do participants miss following the regiment.
Ability to enroll patients who meet the inclusion criteria within the target time frame
时间窗: 12 months
Number of patients recruited
次要结局
- Microbial Diversity(4 weeks)
- BHB Blood Levels(4 weeks)
- Gastrointestinal Symptoms(4 weeks)
- Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)(4 weeks)
- Clinical Response(4 weeks)
- Systemic Inflammation(4 weeks)
- Adverse Events(4 weeks)
- Assess disease activity by Intestinal Ultrasound (IUS)(4 weeks)