A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

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

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

Conditions
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Gastroesophageal Reflux, Regurgitation, Heartburn

Intervention / Treatment
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* Other: Breath Testing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath Test Evaluation for SIBO<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ). | After PPI therapy, approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After PPI therapy, approximately 8 weeks | 
| 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 ). | Baseline | 
| 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton pump inhibitor