Gastroesophageal Reflux, Heartburn, Regurgitation
Conditions
Keywords
Proton pump inhibitor
Brief summary
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
Interventions
OTHERBreath Testing
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
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SIBO after treatment with PPI | After PPI therapy, approximately 8 weeks | Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of SIBO after treatment with PPI | After PPI therapy, approximately 8 weeks | 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 | Baseline | 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 | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndree Koop, MD
Mayo Clinic
Outcome results
None listed