Nursing Management of IBS: Improving Outcomes

描述(由申请人提供)：建议的研究是NINR资助的IBS护理管理研究的竞争性更新：改善结果。肠易激综合征(IBS)是一种常见的慢性功能性肠病，以胃肠道(GI)不适和肠道模式改变为特征。据估计，IBS每年就诊的医生超过200万人次，使其成为美国第四大最昂贵的胃肠道疾病。IBS的负担是通过大量使用的医疗资源和受影响的人与健康相关的生活质量(HRQOL)的下降来衡量的。IBS在美国的患病率为10%-17%，这向医疗保健提供者提出了挑战，要求他们开发和测试有效的治疗策略，以加强患者的自我管理。目前的研究直接建立在我们之前对全面自我管理(CSM)计划的研究基础上，该计划包括认知行为疗法，以减轻IBS患者的胃肠道症状并提高HRQOL。与此同时，有越来越多的证据表明，益生菌可能通过改变肠道菌群来缓解IBS患者的症状。到目前为止，还缺乏益生菌和CSM的正面比较。这项研究的两个重点如下：1)测试益生菌和CSM治疗IBS患者的有效性，并与安慰剂对照组进行比较。主要结果将是腹痛和HRQOL。2)在根据肠道炎症程度定义的患者亚组中，测试益生菌与CSM的相对有效性，通过粪便钙保护素、肠道通透性和血清细胞因子水平来衡量。3)探索其他特征，如基因、精神健康障碍、滥用史、当前焦虑和抑郁水平、下丘脑-垂体-肾上腺轴(皮质醇)、自主神经系统平衡(心率变异性)和症状严重程度是否可以预测哪些患者从益生菌比CSM受益更多，反之亦然。心理和生理措施的使用将不仅提供关于两种不同疗法如何起作用的信息，还将提供它们可能最有效的信息。长期目标是加强对慢性、有时甚至是致残疾病的自我管理。目前的研究直接建立在我们先前对肠易激综合征(IBS)的研究基础上，该研究使用全面的自我管理来减少GI症状和提高生活质量。与此同时，越来越多的证据表明，益生菌可能通过改变肠道菌群起到缓解作用。在临床上，挑战是确定哪种治疗方法最适合个别患者。

DESCRIPTION (provided by applicant): The proposed study is a competitive renewal of the NINR funded study Nursing Management of IBS: Improving Outcomes. Irritable bowel syndrome (IBS) is a common chronic functional bowel disorder characterized by gastrointestinal (GI) discomfort and alterations in bowel pattern. It is estimated that IBS accounts of over 2 million physician visits per year making it the 4th most expensive GI disorder in the U.S. The burden of IBS has been measured in the significant amount of health care resources used and reductions in health related quality of life (HRQOL) in those affected. The 10-17% prevalence of IBS in the U.S. challenges health care providers to develop and test effective therapeutic strategies to enhance patient self management. The current study builds directly on our prior study of a comprehensive self-management (CSM) program that includes cognitive behavioral therapy to reduce GI symptoms and enhance HRQOL in IBS patients. At the same time there is building evidence that probiotics may provide relief for IBS patients via alterations in gut flora. To date, head to head comparison of probiotics with CSM are lacking. The 2 foci of this study are as follows: 1) Test the effectiveness of probiotics and CSM therapy in patients with IBS as compared to a placebo-control group. The primary outcomes will be abdominal pain and HRQOL. 2) Test the relative effectiveness of probiotics compared to CSM in subgroups of patients defined by degree of intestinal inflammation, as measured by fecal calprotectin, intestinal permeability, and serum cytokine levels. 3) Explore whether other characteristics such as genotype, mental health disorders, abuse history, current levels of anxiety and depression, hypothalamic-pituitary-adrenal axis (cortisol), autonomic nervous system balance (heart rate variability), and symptom severity predict which patients will benefit more from probiotics than from CSM and vice versa. The use of both psychologic and physiologic measures will provide information on not only how 2 diverse therapies work but also information on which they might be most effective. The long term goal is to enhance self management of a chronic, and at times, disabling condition. The current study builds directly on our prior study of irritable bowel syndrome (IBS) which used comprehensive self-management to reduce GI symptoms and enhance quality of life. At the same time there is building evidence that probiotics may provide relief via alterations in gut flora. Clinically, the challenge is to identify which treatment is most appropriate for an individual patient.