An observational study in Functional Dyspepsia and Small Intestinal Bacterial Overgrowth, sponsored by Indiana University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Indiana University · Observational
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
Same as above
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 200 is below the median of 248 across 103 observational studies indexed under Diarrhea.
Browse Diarrhea studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
a. All adult patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology
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. for upper endoscopy for any reason v. Prisoners vi. Pregnant vii. Unable to give own
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
In this population, prevalence of potential predictors of SIBO will be compared between subjects with and without a diagnosis of Gram Negative Bacteria SIBO
Time frame: two years
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: 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
Time frame: Two years
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
Time frame: 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
clinical differences between small intestinal bacterial overgrowth by upper respiratory tract bacteria
Time frame: One day
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.
Time frame: One day
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2013 (actual). Primary completion is estimated for Dec 2026, 167 months after the start.
Of 34 non-industry observational studies under Diarrhea, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 167 months is above that.
Counting every sponsor, half of 42 studies reached it within 28 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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