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临床试验/NCT00956397
NCT00956397已完成不适用

Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Henry C. Lin, MD1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT

研究概览

简要总结

The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must have FD based on the most recent Umbrella criteria of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning
  • No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms
  • Criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis
  • The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal

排除标准

  • History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB
  • Inflammatory bowel disease
  • Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria)
  • Anti/pro-biotics last 3 months
  • Previous LBT (Lactulose Breath Test)
  • Narcotic Dependence
  • Pregnancy
  • Control subjects will be excluded if they have symptoms of heartburn, retrosternal chest pain, chronic cough, nausea or regurgitation suggestive of gastroesophageal reflux disease

研究组 & 干预措施

Control Participants

Active Comparator

干预措施: Lactulose Breath Test (Procedure)

FD Participants

Active Comparator

干预措施: Rifaximin (Drug)

FD Participants

Active Comparator

干预措施: Lactulose Breath Test (Procedure)

FD (Placebo) Participants

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT

时间窗: every 15 minutes for 180 minutes

次要结局

  • The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment(2 weeks)

研究者

发起方
Henry C. Lin, MD
申办方类型
Fed
责任方
Sponsor Investigator
主要研究者

Henry C. Lin, MD

Henry C. Lin, MD

New Mexico VA Healthcare System

研究点 (1)

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