Actively Recruiting
Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Led by Mayo Clinic · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how often small intestinal bacterial overgrowth (SIBO) happens after people with gastroesophageal reflux disease (GERD) take proton pump inhibitors (PPIs). The study focuses on patients who have symptoms like heartburn and regurgitation and aims to better understand the relationship between PPI use and SIBO occurrence. This is an interventional study conducted by the Mayo Clinic. Participants with GERD symptoms who have been treated with a short course of PPIs will undergo breath testing to check for SIBO. During the breath test, participants drink a small carbohydrate solution and provide breath samples every 15 minutes for one hour, then every 30 minutes for the next two hours. This testing occurs approximately 8 weeks after PPI therapy to measure SIBO incidence and symptoms. Throughout the study, researchers will assess the presence of SIBO and related symptoms both before and after PPI treatment. Breath testing schedules and symptom evaluations will help determine changes associated with PPI use. The main outcome is the rate of SIBO after PPI therapy, with additional measures of symptoms and SIBO status at baseline. The study does not specify a maximum age and will enroll adults 18 years and older. Participants will be monitored until about 8 weeks after treatment.
CONDITIONS
Brief Title
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
- Subjects must be able to give appropriate informed consent
You will not qualify if you...
- Prior diagnosis of small intestinal bacterial overgrowth (SIBO)
- Use of proton pump inhibitors (PPIs) or H2 receptor antagonists in the prior 3 months
- Major concomitant illness such as renal, hepatic, rheumatologic, 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 breastfeeding
- Patients with plans to become pregnant
- Inability to take proton pump inhibitors including allergy or sensitivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants undergo breath testing to evaluate for small intestinal bacterial overgrowth (SIBO) before and after a short course of proton pump inhibitor (PPI) therapy.
2 visits (in-person) for breath testing, one at baseline and one after PPI therapy
Trial Site Locations
Total: 1 location
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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