CLINICAL TRIAL: CHRONIC ABDOMINAL PAIN DUE TO SMALL INTESTINAL BACTERIAL OVERGRO
CLINICAL TRIAL: CHRONIC ABDOMINAL PAIN DUE TO SMALL INTESTINAL BACTERIAL OVERGRO
批准号:
7982163
负责人:
Bradley Collins
金额:
$6.84万
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-12-01 至 2009-11-30
关键词:
AdultAntibioticsChildChildhoodClinical ResearchClinical TrialsComputer Retrieval of Information on Scientific Projects DatabaseDiseaseDouble-Blind MethodFunctional disorderFundingGoldGrantHydrogenInstitutionIntestinesLactuloseMeasurementPatientsPlacebosPrevalenceQuestionnairesRandomizedResearchResearch PersonnelResourcesSourceSymptomsTestingUnited States National Institutes of Healthchronic abdominal paineffective therapyexperiencerifaximin
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目和
研究者(PI)可能从另一个NIH来源获得了主要资金,
因此可以在其他CRISP条目中表示。所列机构为
研究中心,而研究中心不一定是研究者所在的机构。
慢性腹痛(CAP)是一种非常普遍的儿童疾病,就像成人的IBS一样,它是一种功能性肠道疾病,没有明确的理解框架或有效的治疗方法。然而,新的研究表明,小肠细菌过度生长(SIBO)可能是解释IBS患者所经历的各种症状的统一病理生理学。 由于儿童CAP被认为是成人IBS的前兆,我们假设患有这种疾病的儿童小肠细菌过度生长(SIBO)的患病率明显高于正常健康儿童,并且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。我们将通过对40名健康对照者和80名CAP受试者进行乳果糖呼气氢试验(SIBO非侵入性测量的金标准)来做到这一点。然后我们将评估用抗生素根除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分配80名CAP患者接受10天疗程的抗生素利福昔明或安慰剂。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的细菌过度生长根除情况。我们还将通过重新进行问卷调查来评估症状改善情况。
英文摘要
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.
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