Status:
ENROLLING_BY_INVITATION
Small Intestinal Bacterial Overgrowth: A Prospective Registry
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Progenity, Inc.
Conditions:
Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-90 years
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...
Detailed Description
Same as above
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 7 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01822470
Start Date
January 7 2013
End Date
December 1 2026
Last Update
March 3 2025
Active Locations (1)
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1
Indiana University Hospital
Indianapolis, Indiana, United States, 46202