Small Intestinal Bacterial Overgrowth: A Prospective Registry

NCT ID: NCT01822470

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-07

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Same as above

Conditions

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Functional Dyspepsia Small Intestinal Bacterial Overgrowth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

a. Study Subjects will be recruited from patients who are already undergoing upper enteroscopy and aspiration for diagnosis of SIBO.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Progenity, Inc.

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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John M. Wo

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Wo, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Hospital

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1209009531

Identifier Type: -

Identifier Source: org_study_id

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