NCT04401605招募中不适用
Effects of a Fermented Food-Supplemented on Patients with Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in the clinical disease activity inflammatory marker fecal calprotectin
研究概览
简要总结
The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent
- •Male or female subjects, ≥18 years of age
- •Confirmed diagnosis of UC
- •Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
- •Elevated fecal calprotectin
排除标准
- •Women who are pregnant, nursing or expect to be pregnant
- •Intolerance to fermented food
- •Individuals with a body mass index (BMI) lower than 18
- •Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
- •Individuals who have been severely weakened by a disease or medical procedure
- •Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
- •Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%)
- •History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.
- •Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.
结局指标
主要结局
Change in the clinical disease activity inflammatory marker fecal calprotectin
时间窗: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Change in fecal calprotectin
次要结局
- Clinical remission as per partial Mayo score.(Assessed at Week 10 (Data Collection 2).)
- Clinical response as per partial Mayo score.(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
- Patient global assessment(Assessed at Week 10 (Data Collection 2).)
- Changes in cytokines/chemokines and immune cell profiles(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
- Symptomatic remission as per Patient Reported Outcome (PRO2) score(Assessed at Week 10 (Data Collection 2).)
- Effect of Fermented Food-Supplemented Diet on patient quality of life(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
- Changes in gut microbiome profiles(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
研究者
Sidhartha Ranjit Sinha
Assistant Professor of Medicine (Gastroenterology and Hepatology)
Stanford University
研究点 (2)
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