A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

NCT ID: NCT05976165

Last Updated: 2025-04-17

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2026-01-31

Brief Summary

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Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.

Detailed Description

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Conditions

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Gastroesophageal Reflux Regurgitation Heartburn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Breath Test Evaluation for SIBO

Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).

Group Type EXPERIMENTAL

Breath Testing

Intervention Type OTHER

Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours

Interventions

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Breath Testing

Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
* Subjects must be able to give appropriate informed consent

Exclusion Criteria

* Prior diagnosis of SIBO
* Use of PPIs or H2R-anatagonstists in the prior 3 months
* Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)
* Antibiotic therapy within one month
* Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery
* Previously diagnosed irritable bowel syndrome or inflammatory bowel disease
* Individuals who are pregnant or breast feeding
* Patients with plans to become pregnant
* Inability to take PPIs, including allergy/sensitivity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andree H. Koop

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andree Koop, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Andree H Koop, MD

Role: primary

9049533970

Other Identifiers

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22-007268

Identifier Type: -

Identifier Source: org_study_id

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