CLINICAL TRIAL: CHRONIC ABDOMINAL PAIN DUE TO SMALL INTESTINAL BACTERIAL OVERGRO

临床试验：小肠细菌过度生长引起的慢性腹痛

• 批准号: 7982163
• 负责人: Bradley Collins
• 金额: $ 6.84万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982163
• 关键词: Adult; Antibiotics; Child; Childhood; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Double-Blind Method; Functional disorder; Funding; Gold; Grant; Hydrogen; Institution; Intestines; Lactulose; Measurement; Patients; Placebos; Prevalence; Questionnaires; Randomized; Research; Research Personnel; Resources; Source; Symptoms; Testing; United States National Institutes of Health; chronic abdominal pain; effective therapy; experience; rifaximin

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 慢性腹痛(CAP)是一种非常普遍的儿童疾病，与成人的IBS一样，它是一种缺乏明确认识或有效治疗的功能性肠道疾病。然而，新的研究表明，小肠细菌过度生长(SIBO)可能是解释IBS患者经历的各种症状的统一病理生理学。由于儿童的CAP被认为是成人IBS的先兆，我们假设患有这种疾病的儿童的小肠细菌过度生长(SIBO)的患病率显著高于正常、健康的儿童，使用抗生素根除细菌过度生长将减少患有这种疾病的儿童的慢性腹痛症状。为了证明这一点，我们将首先确定SIBO在健康儿童和CAP儿童中的患病率。为此，我们将在40名健康对照组和80名CAP患者上进行乳果糖呼气氢测试，这是无创测量SIBO的金标准。然后，我们将评估使用抗生素根除SIBO是否会减少患有这种疾病的儿童的慢性腹痛症状。为了做到这一点，我们将以双盲的方式随机选择80名CAP患者，接受为期10天的抗生素利福昔明或安慰剂治疗。治疗完成后，我们将通过重复乳果糖呼气氢试验来评估所有这些患者是否根除了细菌过度生长。我们还将通过重新发放问卷来评估症状改善情况。