Recurrent Abdominal Pain in Children

描述（由申请人提供）：10 - 17%的4-16岁儿童有复发性腹痛（RAP）。其中，高达68%的人符合肠易激综合征（IBS）的标准，这也影响了15% - 20%的成年人。高达66%的RAP患儿成年后会发展为肠易激综合征。本项目重点研究RAP （ibs型）患儿的治疗方法和病理生理机制。采用随机、双盲、安慰剂对照设计，我们的具体目标是，在患有RAP-IBS的儿童中：1)表征可溶性纤维与益生菌在改善症状方面的有效性，与安慰剂相比（疼痛发作次数、疼痛严重程度的平均评分、疼痛引起的活动干扰和正常大便的百分比；主要终点）；2)通过测量胃肠道（Gl）功能测试，确定可溶性纤维或益生菌改善RAP-IBS患儿症状的潜在机制：Gl传递时间、呼吸产氢量、Gl通透性和粪便钙保护蛋白浓度；二次端点);3)定义心理构形（儿童焦虑、躯体化、应对、父母躯体化、应对和疾病相互作用）在解释对治疗的反应（疼痛发作次数、疼痛严重程度的平均评分、疼痛引起的活动干扰）中的潜在贡献。我们假设：1)与安慰剂相比，服用可溶性纤维或益生菌可改善RAP-IBS相关症状；2)可溶性纤维和/或益生菌将改善Gl功能测试：使Gl传递时间正常化，降低呼吸产氢量、Gl通透性和粪便钙保护蛋白浓度；3)在控制了治疗和Gl功能测试的效果后，心理构念将作为治疗效果的调节因子，通过疼痛发作次数的变化、疼痛严重程度的平均评分和对活动的干扰来衡量。这项建议的结果可能会使大量患有RAP-IBS的儿童受益，并可能为其预防或症状改善提供见解。确定影响儿童症状的因素可能适用于成人。儿童期的干预可以通过改变这些儿童的生理和学习/条件反射和适应经验来预防或改善成人的症状。我们预计这些数据可以用来解决这些疾病带来的重大情感和经济负担，成年人每年的经济负担接近80亿美元。

DESCRIPTION (provided by applicant): Ten to 17 percent of children 4-16 years have recurrent abdominal pain (RAP). Of these, up to 68 percent meet the criteria for irritable bowel syndrome (IBS), which also affects 15 - 20 percent of adults. Up to 66 percent of children with RAP develop IBS as adults. This project focuses on developing treatments and understanding the pathophysiology in children with RAP (IBS-type). Using a randomized, double blind, placebo controlled design, our Specific Aims are, in children with RAP-IBS, to: 1) Characterize the effectiveness of soluble fiber versus a probiotic compared with placebo in improving symptoms (number of pain episodes, mean rating of pain severity, pain-induced interference with activities, and percent of stools that are normal; primary endpoints); 2) Identify potential mechanisms whereby soluble fiber or a probiotic improve symptoms in children with RAP-IBS by measuring gastrointestinal (Gl) function tests: Gl transit time, breath hydrogen production, Gl permeability, and fecal calprotectin concentration; secondary endpoints); and 3) Define the potential contribution of psychological constructs (child anxiety, somatization, coping, and parental somatization, coping, and illness interaction) in explaining the response to the treatments (number of pain episodes, mean rating of pain severity, pain-induced interference with activities). We Hypothesize that: 1) Administration of soluble fiber or a probiotic will improve reported symptoms associated with RAP-IBS compared with placebo; 2) Soluble fiber and/or a probiotic will improve Gl function tests: normalize Gl transit time, decrease breath hydrogen production, Gl permeability, and fecal calprotectin concentration; and 3) After controlling for the effects of treatment and Gl function tests, psychological constructs will serve as moderators of treatment effects as measured by a change in the number of pain episodes, mean rating of pain severity, and interference with activities. The results of this proposal likely will benefit the large numbers of children with RAP-IBS and potentially provide insight into its prevention or symptom amelioration. Identification of factors influencing symptoms in children is likely to apply to adults. Interventions in childhood may prevent or ameliorate symptoms in adults by changing the physiological and the learning/conditioning and adaptive experience of these children. We anticipate these data can used to address the significant emotional and economic burdens of these disorders, which in adults is near eight billion dollars per year.