Nursing Management of IBS: Improving Outcomes

描述（由申请人提供）：拟议的研究是NINR资助的研究IBS护理管理的竞争性更新：改善结果。肠易激综合征（IBS）是一种常见的慢性功能性肠道疾病，以胃肠道不适和肠道模式改变为特征。据估计，IBS占每年超过200万的医生访问，使其成为美国第四大最昂贵的GI疾病。IBS的负担已被衡量为使用的大量医疗保健资源和受影响者的健康相关生活质量（HRQOL）下降。在美国，IBS的患病率为10-17%，这对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，以增强患者的自我管理。目前的研究直接建立在我们之前对综合自我管理（CSM）计划的研究基础上，该计划包括认知行为治疗，以减少IBS患者的GI症状并提高HRQOL。同时，有证据表明益生菌可以通过改变肠道植物群来缓解IBS患者。迄今为止，缺乏益生菌与CSM的头对头比较。本研究的两个焦点如下：1）测试益生菌和CSM治疗与安慰剂对照组相比在IBS患者中的有效性。主要结局为腹痛和HRQOL。2)测试益生菌与CSM相比在由肠道炎症程度定义的患者亚组中的相对有效性，如通过粪便钙卫蛋白、肠道通透性和血清细胞因子水平测量的。3)探索其他特征，如基因型，精神健康障碍，滥用史，焦虑和抑郁的当前水平，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预测哪些患者将从益生菌中获益更多而不是CSM，反之亦然。心理和生理测量的使用不仅提供了关于2种不同疗法如何工作的信息，而且还提供了关于它们可能最有效的信息。长期目标是加强对慢性病的自我管理，有时甚至是致残性疾病。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症状并提高生活质量。同时，有证据表明益生菌可以通过改变肠道植物群来缓解症状。在临床上，挑战是确定哪种治疗方法最适合个体患者。

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.