Small Intestinal Bacterial Overgrowth: A Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO
研究概览
简要总结
The purpose of this study is to investigate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient procedure with symptoms of functional dyspepsia. In addition, the investigators would like to identify the types of bacteria that are present in the small intestines in patients with SIBO and compare two different diagnostic tools: microbiologic culture and DNA sequencing of bacteria.
The aim is to compare the microbiota between patients with and without the clinical complications of SIBO
详细描述
Same as above
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Study Subjects Inclusion Criteria i. All patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology.
排除标准
- •i. Use of colon cleansing prep in the past 1 month ii. Treatment with antibiotics in the past 30 days (antibiotics are allowable for patients undergoing clinical indicated repeat aspiration to determine bacteria clearance) iii. Use of probiotics in the past 30 days iv. Contraindication for upper endoscopy for any reason v. Prisoners vi. Pregnant vii. Unable to give own informed consent
- •2 Control Subjects Inclusion Criteria i. Patients who are undergoing double balloon enteroscopy or upper enteroscopy for another medical reason.
- •Exclusion Criteria i. Diagnosis of SIBO ii. Diagnosis of functional dyspepsia iii. Established risk factors for SIBO (ANY of the following)
- •Connective tissue disorder (scleroderma, polymyositis, mixed connective tissue disease, or systemic lupus
- •Resection of ileocecal valve for any reason
- •Chronic intestinal pseudo-obstruction
- •Small bowel blind limb, diverticulum or fistula
- •Surgery with decreased gastric acid exposure for small bowel a. Gastric surgery with vagotomy (Bilroth I, Bilroth II, vagotomy/pyloroplasty) or gastric bypass iv. Use of colon cleansing prep in the past 1 month v. Use of antibiotics in the past 30 days vi. Use of probiotics in the past 30 days vii. Contraindication for upper endoscopy for any reason viii. Prisoners ix. Pregnant x. Unable to give own informed
研究组 & 干预措施
Study group
a. Study Subjects will be recruited from patients who are already undergoing upper enteroscopy and aspiration for diagnosis of SIBO.
Control group
b. Control Subjects will be recruited from patients who are already undergoing a double balloon enteroscopy or upper enteroscopy for another medical reason
结局指标
主要结局
To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO
时间窗: two years
In this population, prevalence of potential predictors of SIBO will be compared between subjects with and without a diagnosis of Gram Negative Bacteria SIBO
次要结局
- Compare the composition between luminal and mucosal bacteria in the proximal small bowel(One day)
- Characterize the clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria and small intestinal bacterial overgrowth by gram-negative bacilli bacteria(One day)
- A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth(Two years)
- The demographics, clinical history, and symptoms in patients with and without SIBO(One day)
研究者
John M. Wo
Professor of Medicine
Indiana University