Small Intestinal Bacterial Overgrowth: A Prospective Registry

NCT01822470 | Enrolling By Invitation

• 1 other identifier: 1209009531
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Dyspepsia; Small Intestinal Bacterial Overgrowth

Keywords

functional dyspepsia; post prandial distress syndrome; small bowel bacteria overgrowth; epigastric pain syndrome; diarrhea; bloating; post prandial fullness; weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth

  Two years

• The demographics, clinical history, and symptoms in patients with and without SIBO

  One day

• 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

• Compare the composition between luminal and mucosal bacteria in the proximal small bowel

  One day

Study Arms (2)

Study group

a. Study Subjects will be recruited from patients who are already undergoing upper enteroscopy and aspiration for diagnosis of SIBO.

Control group

b. Control Subjects will be recruited from patients who are already undergoing a double balloon enteroscopy or upper enteroscopy for another medical reason

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

a. All adult patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Progenity, Inc.: collaborator

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be kept from patients jejunal aspirate and mucosal biopsy. In addition, patient serum will be kept

MeSH Terms

Conditions

Diarrhea; Weight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Study Officials

• John Wo, MD

  Indiana University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 2, 2013
• Study Start: January 7, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-08

Locations

US (1)