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

摘要 这项申请提出了美国农业部健康地中海式食品的试点可行性随机试验 对PAS-20-160反应的憩室炎患者纤维摄入模式与标准化指南的比较 NIDDK任务范围内针对疾病的临床试验的小型R01。憩室炎是最常见的 住院、门诊和急诊室就诊的常见胃肠道指征， 还有结肠手术。至少20%的初发憩室炎患者会有一次或多次疼痛 以及不可预测的复发。不幸的是，目前还没有被证实的药物方法来降低心脏病的风险。 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危险因素 憩室炎。在一项研究中，坚持低风险特征(51克/天红肉，23克/天纤维，2小时)的男性 每周锻炼、体重指数正常、从不吸烟)患憩室炎的可能性降低75%。然而， 这些可改变的危险因素尚未评估为二级预防。饮食与血浆的研究 炎症标志物提示慢性全身性炎症是一种潜在的机制 饮食对憩室炎发生的影响。地中海饮食模式可与相关饮食相媲美 作为憩室炎的一级预防，与减少炎症有更强的相关性，并且熟悉 提供者和许多病人。因此，我们建议对美国农业部健康的Med进行一项随机试验(n=75)。 憩室炎患者膳食方式与纤维摄入量标准化指导的对比研究 这种饮食干预的可行性，包括愿意随机和坚持地中海式饮食 图案。我们将以电子反馈的形式采用最先进的行为干预措施来改善 与健康相关的行为，并支持基于参与者预算、饮食偏好 和限制。我们还将检测血浆炎症生物标志物(白介素6、白介素10和 在基线、6个月和12个月时检测血清白介素1(β)和粪便钙保护素。拟议的可行性试验将设定 食物模式的大型多中心随机对照试验的基础--行为干预与标准化指导 有憩室炎病史患者的纤维摄入量。它还将扩大我们对炎症和 憩室炎的发病机制，并收集前瞻性收集的样本，用于未来的生物标记物研究。最终， 鉴于憩室炎的流行和发病率以及缺乏预测性和预防性措施， 确定已证实的二级预防手段和风险生物标记物将改变治疗模式 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.