Breath testing for small intestinal bacterial overgrowth after proton pump inhibitors
Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
This study is testing if people with gastroesophageal reflux symptoms who have taken proton pump inhibitors have a higher chance of having small intestinal bacterial overgrowth by using breath tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05976165 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients experiencing gastroesophageal reflux symptoms who have been treated with proton pump inhibitors (PPIs). Participants will undergo breath testing to assess the presence of SIBO following their PPI treatment. The study seeks to provide insights into the relationship between PPI use and the occurrence of SIBO, which may have implications for managing gastroesophageal reflux disease. By understanding this connection, researchers hope to improve treatment strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing predominant symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation, who have not used PPIs or H2R-antagonists in the past three months.
Not a fit: Patients with a prior diagnosis of SIBO, major concomitant illnesses, or those who have undergone gastrointestinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of gastroesophageal reflux disease by identifying and addressing SIBO in patients treated with PPIs.
How similar studies have performed: While the relationship between PPIs and SIBO is being explored, this specific approach of breath testing in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Andree Koop, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.