Back to resultsA Study of Breath Testing for Small Intestinal Bacterial Overgrowth
Primary Purpose
Gastroesophageal Reflux, Regurgitation, Heartburn
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breath Testing
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Proton pump inhibitor
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breath Test Evaluation for SIBO
Arm Description
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).
Outcomes
Primary Outcome Measures
Incidence of SIBO after treatment with PPI
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).
Secondary Outcome Measures
Symptoms of SIBO after treatment with PPI
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.
Incidence of SIBO before treatment with a PPI
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).
Symptoms of SIBO before treatment with a PPI
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05976165
Brief Title
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
Official Title
Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Regurgitation, Heartburn
Keywords
Proton pump inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breath Test Evaluation for SIBO
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Breath Testing
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of SIBO after treatment with PPI
Description
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).
Time Frame
After PPI therapy, approximately 8 weeks
Secondary Outcome Measure Information:
Title
Symptoms of SIBO after treatment with PPI
Description
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.
Time Frame
After PPI therapy, approximately 8 weeks
Title
Incidence of SIBO before treatment with a PPI
Description
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).
Time Frame
Baseline
Title
Symptoms of SIBO before treatment with a PPI
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andree Koop, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
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