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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01822470
Other study ID # 1209009531
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 2013
Est. completion date December 2025

Study information

Verified date February 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Description:

Same as above


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University Progenity, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO In this population, prevalence of potential predictors of SIBO will be compared between subjects with and without a diagnosis of Gram Negative Bacteria SIBO two years
Secondary A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth 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:
Demographics
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index total and subscale scores
Presence of functional gastrointestinal disorders
Established risk factors of gram negative small intestinal bacterial overgrowth.
Established risk factors of upper respiratory tract small intestinal bacterial overgrowth
Two years
Secondary The demographics, clinical history, and symptoms in patients with and without SIBO 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
One day
Secondary Characterize the clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria and small intestinal bacterial overgrowth by gram-negative bacilli bacteria clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria One day
Secondary Compare the composition between luminal and mucosal bacteria in the proximal small bowel Compare the results of bacteria species isolated from molecular polymerase chain reaction identification between luminal aspiration samples and mucosa biopsy samples. One day
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