Functional DyspepsiaSIBONCT01822470
Small Intestinal Bacterial Overgrowth: A Prospective Registry
An observational study of Functional Dyspepsia and Small Intestinal Bacterial Overgrowth, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Functional Dyspepsia, Small Intestinal Bacterial Overgrowth
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2013to Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
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
Read the detailed description
Same as above
- Keywords
- functional dyspepsia, post prandial distress syndrome, small bowel bacteria overgrowth, epigastric pain syndrome, diarrhea, bloating, post prandial fullness, weight loss
- Medical subject headings
- Diarrhea, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Secondary outcomes (4)
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:
- Demographics
- 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
Measured: 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.
- Established risk factors of upper respiratory tract small intestinal bacterial overgrowth
Measured: 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
Measured: 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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study start7 Jan 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Progenity, Inc.
- Responsible party
- Principal investigator, John M. Wo, Indiana University
- Investigators
- John Wo, MD, Principal investigator, Indiana University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822470
- Sponsor's protocol ID
- 1209009531
- Acronym
- SIBO
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2013
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestinal Bacterial Overgrowth: A Prospective Registry
- ClinicalTrials.gov ID
- NCT01822470
- Acronym / sponsor ID
- SIBO / 1209009531
- Keywords
- functional dyspepsia, post prandial distress syndrome, small bowel bacteria overgrowth, epigastric pain syndrome, diarrhea, bloating, post prandial fullness, weight loss
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Progenity, Inc.
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a. All adult patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
A registry of patients undergoing proximal jejunal aspiration for suspected small intestinal bacterial overgrowth
Time frame: Two years
The demographics, clinical history, and symptoms in patients with and without SIBO
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
Time frame: One day
Compare the composition between luminal and mucosal bacteria in the proximal small bowel
Time frame: One day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Wo, MD principal investigator
Indiana University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and Small Intestinal Bacterial Overgrowth, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.