Functional Dyspepsia, Small Intestinal Bacterial Overgrowth
Conditions
Keywords
functional dyspepsia, post prandial distress syndrome, small bowel bacteria overgrowth, epigastric pain syndrome, diarrhea, bloating, post prandial fullness, weight loss
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
Interventions
None listed
Sponsors
Indiana University
Progenity, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the predictors for SIBO in patients with functional dyspepsia, who do not have the established risk factors for SIBO | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth | 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: 1. 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 |
| The demographics, clinical history, and symptoms in patients with and without SIBO | 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 | 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 | One day | Compare the results of bacteria species isolated from molecular polymerase chain reaction identification between luminal aspiration samples and mucosa biopsy samples. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Wo, MD
Indiana University Hospital
Outcome results
None listed