Small Intestinal Bacterial Overgrowth: a Prospective Registry

• Conditions: Functional Dyspepsia; Small Intestinal Bacterial Overgrowth

• Registration Number: NCT01822470
• Lead Sponsor: Indiana University

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 Timeline

• Study Start: 2013-01-07
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO	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 Outcome Measures

Name	Time	Method
The demographics, clinical history, and symptoms in patients with and without SIBO	One day	Demographics 2. Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index total and subscale scores 3. Presence of functional gastrointestinal disorders 4. Established risk factors of gram negative small intestinal bacterial overgrowth.; 5. Established risk factors of upper respiratory tract small intestinal bacterial overgrowth
Compare the composition between luminal and mucosal bacteria in the proximal small bowel	One day	Compare the results of bacteria species isolated from molecular polymerase chain reaction identification between luminal aspiration samples and mucosa biopsy samples.
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	clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria
A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth	Two years	A prospective registry will be created for all subjects who are undergoing jejunal aspirate for clinical indications. Private health information will be excluded from the data registry. Data collected for the registry will include: 1. Demographics; 2. Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index total and subscale scores; 3. Presence of functional gastrointestinal disorders; 4. Established risk factors of gram negative small intestinal bacterial overgrowth.; 5. Established risk factors of upper respiratory tract small intestinal bacterial overgrowth

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States