A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

November 17, 2023 updated by: Andree H. Koop, Mayo Clinic

Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SIBO after treatment with PPI
Time Frame: After PPI therapy, approximately 8 weeks
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).
After PPI therapy, approximately 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SIBO before treatment with a PPI
Time Frame: Baseline
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).
Baseline
Symptoms of SIBO after treatment with PPI
Time Frame: After PPI therapy, approximately 8 weeks
Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention. Other questionnaires include a diarrhea survey and the GERDQ.
After PPI therapy, approximately 8 weeks
Symptoms of SIBO before treatment with a PPI
Time Frame: Baseline
Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention. Other questionnaires include a diarrhea survey and the GERDQ.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andree Koop, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

May 17, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-007268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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