Small Intestinal Bacterial Overgrowth: A Prospective Registry



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 90
Updated:10/10/2018
Start Date:January 2013
End Date:December 2020
Contact:Anita Gupta, MBBS,MPH
Email:anigupta@iu.edu
Phone:317 948 9227

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Trial Summary
Trial Overview
Inclusion Criteria
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

Same as above

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)

1. Connective tissue disorder (scleroderma, polymyositis, mixed connective tissue
disease, or systemic lupus

2. Resection of ileocecal valve for any reason

3. Chronic intestinal pseudo-obstruction

4. Small bowel blind limb, diverticulum or fistula

5. 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
We found this trial at
1
site
Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
Phone: 317-948-9227
?
mi
from
Indianapolis, IN
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