Small Intestinal Bacterial Overgrowth: A Prospective Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Indiana University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO
Study Overview
Brief Summary
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
Detailed Description
Same as above
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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
Outcomes
Primary Outcomes
To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
John M. Wo
Professor of Medicine
Indiana University