Gastroesophageal Reflux Clinical Trial
Official title:
Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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