Small Intestinal Bacterial Overgrowth: A Prospective Registry

Обзор

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

Подробное описание

Same as above

Первичные конечные точки

• To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO [Срок оценки: two years]

Вторичные конечные точки (4)

• A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth [Срок оценки: Two years]
• The demographics, clinical history, and symptoms in patients with and without SIBO [Срок оценки: 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 [Срок оценки: One day]
• Compare the composition between luminal and mucosal bacteria in the proximal small bowel [Срок оценки: One day]

Критерии участия

1.Study Subjects Inclusion Criteria i. All patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology.

Exclusion Criteria 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Indiana University Hospital — Indianapolis

Идентификаторы

NCT: NCT01822470 · 1209009531

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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