Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial

摘要 这项申请提出了一个试点的可行性随机试验的美国农业部健康地中海式食品 憩室炎患者对PAS-20-160反应的纤维摄入模式与标准化指南， 针对NIDDK使命内疾病的临床试验的小型R 01。憩室炎是最常见的 住院、门诊和急诊室就诊的常见胃肠道适应症， 和结肠手术至少有20%的人与憩室炎的初始发作将有一个或多个痛苦的 和不可预测的复发。不幸的是，没有经过证实的药理学方法来降低 憩室炎。大型的前瞻性观察性研究已经确定了饮食和生活方式的风险因素， 憩室炎在一项研究中，坚持低风险的男性（<51克/天红肉，> 23克/天纤维，2小时 运动量/周，BMI正常，从不吸烟）发生憩室炎的可能性降低75%。然而，在这方面， 这些可改变的风险因素尚未被评估用于二级预防。饲料和血浆研究 炎症标志物提示慢性全身性炎症是一种潜在的机制， 饮食对憩室炎发展的影响。地中海饮食模式与相关的饮食模式相当， 与憩室炎的一级预防相关，与炎症减少相关性更强， 供应商和许多患者。因此，我们建议进行一项随机试验（n=75）的美国农业部健康医学- 食物模式与标准化指导纤维摄入量的憩室炎患者，以评估 这种饮食干预的可行性，包括随机化的意愿和对Med-style饮食的坚持 格局我们将以电子反馈的形式采用最先进的行为干预措施， 健康相关行为，并支持基于参与者预算、饮食偏好 和限制。我们还将检查血浆炎症生物标志物（白细胞介素-6，白细胞介素-10和白细胞介素-10）。 白细胞介素-1 β）和粪便钙卫蛋白。拟议的可行性试验将确定 食物模式-行为干预与标准化指导的大型多中心RCT的基础 对有憩室炎病史的患者纤维摄入量的影响。它还将扩大我们对炎症的了解， 憩室炎的发病机制，并收集前瞻性收集的样本用于未来的生物标志物研究。最后， 鉴于憩室炎的流行和发病率以及缺乏预测和预防措施， 确定一种经过验证的二级预防方法和一种风险生物标志物将改变治疗模式， 并改善数百万憩室炎患者的生活。

ABSTRACT This application proposes a pilot feasibility randomized trial of the USDA Healthy Mediterranean-style Food Pattern versus standardized guidance on fiber intake for patients with diverticulitis in response to PAS-20-160, Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK. Diverticulitis is one of the most common gastrointestinal indications for inpatient hospital admission, outpatient clinic and emergency room visits, and colon surgery. At least 20% of individuals with an initial episode of diverticulitis will have one or more painful and unpredictable recurrences. Unfortunately, there is no proven pharmacologic means to decrease the risk of diverticulitis. Large, prospective, observational studies have identified diet and lifestyle risk factors for incident diverticulitis. In one study, men who adhered to a low-risk profile (< 51g/day red meat, >23g/day fiber, 2 hours exercise/week, normal BMI, and never smoked) were 75% less likely to develop incident diverticulitis. However, these modifiable risk factors have not been evaluated for secondary prevention. Studies of diet and plasma inflammatory markers suggest that chronic, systemic inflammation is a potential mechanism that underlies the dietary effects on diverticulitis development. The Mediterranean diet pattern is comparable to diets associated with primary prevention of diverticulitis, is more strongly associated with reduced inflammation, and is familiar to providers and many patients. Thus, we propose to conduct a randomized trial (n=75) of a USDA Healthy Med- style Food Pattern versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. We will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participant’s budget, dietary preferences, and restrictions. We will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months. The proposed feasibility trial will set the groundwork for a large multicenter RCT of a food pattern–behavioral intervention versus standardized guidance on fiber intake in patients with a history of diverticulitis. It will also expand our knowledge of inflammation and diverticulitis pathogenesis and gather prospectively collected samples for future biomarker study. Ultimately, given the prevalence and morbidity of diverticulitis and the lack of predictive and preventative measures, identifying a proven means of secondary prevention and a biomarker of risk would change treatment paradigms and improve the lives of millions of patients with diverticulitis.