Recurrent Abdominal Pain in Children

描述(申请人提供)：10%至17%的4-16岁儿童有反复腹痛(RAP)。其中，高达68%的人符合肠易激综合征(IBS)的标准，这种综合征也影响15%-20%的成年人。高达66%的RAP儿童成年后会患上IBS。这个项目的重点是开发治疗和了解儿童RAP(IBS类型)的病理生理学。采用随机、双盲、安慰剂对照设计，我们的具体目标是：1)比较可溶性纤维和益生菌在改善症状方面的有效性(疼痛发作次数、疼痛严重程度的平均评级、疼痛对活动的干扰以及正常大便的百分比；主要终点)；2)通过测量胃肠(Gl)功能测试确定可溶性纤维或益生菌改善RAP-IBS儿童症状的潜在机制：GL转运时间、氢气产生、Gl通透性和粪便钙保护素浓度；次级终点；3)确定心理结构(儿童焦虑、躯体化、应对、父母躯体化、应对和疾病互动)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级、疼痛对活动的干扰)方面的潜在贡献。我们假设：1)与安慰剂相比，服用可溶性纤维或益生菌将改善已报告的与RAP-IBS相关的症状；2)可溶性纤维和/或益生菌将改善Gl功能测试：使Gl通过时间正常化，减少呼气氢产生、Gl通透性和粪便钙保护素浓度；3)在控制了治疗和Gl功能测试的效果后，心理结构将作为治疗效果的调节因素，通过疼痛发作次数、平均疼痛严重程度评级和活动干扰来衡量。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洞察力。确定影响儿童症状的因素很可能适用于成人。对儿童的干预可以通过改变这些儿童的生理和学习/适应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巨大情感和经济负担，成年人每年的负担接近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.