OUTCOMES ASSESSMENT IN PEDIATRIC H PYLORI GASTRITIS

小儿幽门螺杆菌胃炎的结果评估

• 批准号: 2701251
• 负责人: B U LI
• 金额: $ 6.8万
• 依托单位: CHILDREN'S HOSPITAL (COLUMBUS)
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-25 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2701251
• 关键词: Helicobacter; antibiotics; biomarker; breath tests; child (0-11); chronic pain; clinical research; clinical trials; functional ability; gastrins; gastritis; gastrointestinal disorder chemotherapy; human subject; human therapy evaluation; longitudinal human study; online computer; outcomes research; patient monitoring device; pediatrics; pepsinogens; quality of life; reflux esophagitis; telecommunications; telemetry

DESCRIPTION (taken directly from the application) The gastric response to Helicobacter pylori (Hp) differs between children and adults. In children, gastritis is the most common manifestation whereas peptic ulcers are uncommon. The issues of whether Hp gastritis induces recurrent abdominal pain and requires treatment remain current controversies in pediatric gastroenterology. Prior studies on treatment outcomes in pediatric II. pylori gastritis have had three limitations: symptomatic responses have been evaluated only at a single short-term point 4 to 8 weeks after initiation of therapy, quality of life indicators relevant to children have not been measured, and the contribution of psychological variables has not been assessed. To address these limitations and provide a more rigorous study of therapeutic responses to Hp eradication, we propose to: 1) develop a computerized outcomes telemonitoring system to assess both GI symptoms (e.g. intensity and duration of pain) and quality of life (e.g. school attendance) for 2 years; 2) compare with effects of clinical outcomes of triple eradication therapy for H. pylori with that of gastritis treatment alone; 3) relate the temporal response to treatment to three indirect markers of gastric recovery including bacterial eradication (13C-urea breath test), gastric inflammation (serum pepsinogen I), and gastrin secretion (plasma gastrin, gastrin-releasing peptide, somatostatin); and 4) determine if psychological factors and medical non-compliance influence treatment outcomes. This novel computerized outcomes methodology will enable us to prospectively and continuously (twice weekly) assess both short and long- term treatment response by administering a pre-recorded questionnaire over a telephone modem; the subject's response entered by telephone keypad will be directly transferred into our database. If validated, this automated outcomes assessment tool could be used in multi-center trials in pediatric Hp gastritis to study the relative efficacy of various therapeutic regimens, or, to study other GI disorders in which either the relationship between pathologic finding and symptomatology is in question.

描述（直接从申请中获取） 儿童之间对幽门螺杆菌（HP）的胃反应不同 和成人。在儿童中，胃炎是最常见的表现 而消化性溃疡并不常见。 HP胃炎的问题 诱导复发性腹痛并需要治疗仍在 小儿胃肠病学的争议。先前的治疗研究 小儿II的结果。幽门螺杆菌有三个局限性： 有症状的反应仅在短期内评估 开始治疗后4到8周，生活质量指标 与儿童有关，尚未衡量 心理变量尚未评估。解决这些 局限性并提供对治疗反应的更严格研究 消除惠普，我们建议：1）开发计算机化结果 远程监控系统评估两个GI症状（例如强度和强度 痛苦的持续时间）和生活质量（例如上学） 年; 2）与三重根除的临床结果相比 幽门螺杆菌的治疗仅与胃炎治疗的治疗； 3）相关 对胃的三个间接标记的治疗的时间反应 恢复包括细菌根除（13C-rea呼气测试），胃 炎症（血清胃蛋白原I）和胃泌素分泌（血浆胃蛋白，， 胃蛋白释放肽，生长抑素）； 4）确定是否 心理因素和医学违规影响治疗 结果。这个新颖的计算机化结果方法将使我们能够 前瞻性，连续（每周两次）评估简短和长期 通过对预先录制的调查表进行术语治疗响应 电话调制解调器；由电话键盘输入的对象的回答将 直接转移到我们的数据库中。如果已验证，则自动化 结果评估工具可用于小儿多中心试验 HP胃炎研究各种治疗的相对功效 治疗方案，或研究其他关系疾病的其他gi疾病 在病理发现和症状学之间是有问题的。