Clinical trial NCT01822470: Small Intestinal Bacterial Overgrowth: A Prospective Registry
Official title: Small Intestinal Bacterial Overgrowth: A Prospective Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Progenity, Inc.
First posted: 2013-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a. All adult patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology

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

Eligibility criteria: 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

Primary outcomes:
measure: To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO
timeFrame: two years
Secondary outcomes:
measure: A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth
timeFrame: Two years
measure: The demographics, clinical history, and symptoms in patients with and without SIBO
timeFrame: One day
measure: Characterize the clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria and small intestinal bacterial overgrowth by gram-negative bacilli bacteria
timeFrame: One day
measure: Compare the composition between luminal and mucosal bacteria in the proximal small bowel
timeFrame: One day
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: John Wo, MD
role: PRINCIPAL_INVESTIGATOR
References: