Small Intestinal Bacterial Overgrowth: A Prospective Registry (SIBO)
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|ClinicalTrials.gov Identifier: NCT01822470|
Recruitment Status : Enrolling by invitation
First Posted : April 2, 2013
Last Update Posted : February 14, 2022
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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
|Condition or disease|
|Functional Dyspepsia Small Intestinal Bacterial Overgrowth|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Small Intestinal Bacterial Overgrowth: A Prospective Registry|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
a. Study Subjects will be recruited from patients who are already undergoing upper enteroscopy and aspiration for diagnosis of SIBO.
b. Control Subjects will be recruited from patients who are already undergoing a double balloon enteroscopy or upper enteroscopy for another medical reason
- To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO [ Time Frame: 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
- A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth [ Time Frame: 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:
- 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
- The demographics, clinical history, and symptoms in patients with and without SIBO [ Time Frame: 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
- Characterize the clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria and small intestinal bacterial overgrowth by gram-negative bacilli bacteria [ Time Frame: One day ]clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria
- Compare the composition between luminal and mucosal bacteria in the proximal small bowel [ Time Frame: One day ]Compare the results of bacteria species isolated from molecular polymerase chain reaction identification between luminal aspiration samples and mucosa biopsy samples.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822470
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||John Wo, MD||Indiana University Hospital|
|Responsible Party:||John M. Wo, Professor of Medicine, Indiana University|
|Other Study ID Numbers:||
|First Posted:||April 2, 2013 Key Record Dates|
|Last Update Posted:||February 14, 2022|
|Last Verified:||February 2022|
post prandial distress syndrome
small bowel bacteria overgrowth
epigastric pain syndrome
post prandial fullness
Signs and Symptoms, Digestive