Small Intestinal Bacterial Overgrowth: A Prospective Registry

Functional Dyspepsia Clinical Trial

— SIBO  

Official title:

Small Intestinal Bacterial Overgrowth: A Prospective Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01822470
• Other study ID #: 1209009531
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Small Intestinal Bacterial Overgrowth

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