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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
Sponsor:
Collaborator:
Progenity, Inc.
Information provided by (Responsible Party):
John M. Wo, Indiana University

Study Description
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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


Condition or disease
Functional Dyspepsia Small Intestinal Bacterial Overgrowth

Detailed Description:
Same as above
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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:

    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

  2. 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


  3. 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

  4. 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
DNA will be kept from patients jejunal aspirate and mucosal biopsy. In addition, patient serum will be kept

Eligibility Criteria
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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
Study Population
a. All adult patients who are undergoing small bowel aspiration for suspected SIBO regardless etiology
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Progenity, Inc.
Investigators
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Principal Investigator: John Wo, MD Indiana University Hospital
More Information
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Additional Information:

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Responsible Party: John M. Wo, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01822470    
Other Study ID Numbers: 1209009531
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Keywords provided by John M. Wo, Indiana University:
functional dyspepsia
post prandial distress syndrome
small bowel bacteria overgrowth
epigastric pain syndrome
 diarrhea
bloating
post prandial fullness
weight loss
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive