The Impact of Proton Pump Inhibitors on the Fecal Microbiome
- Registration Number
- NCT01822977
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (CDI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proton pump inhibitor omeprazole We will recruit 10 healthy adult individuals and 5 adult patients with an initial episode of CDI cared for at Mayo Clinic in Arizona. A baseline stool sample will be collected from the healthy individuals. They will then be given a PPI, omeprazole 20 mg, to be taken once (n=5) or twice (n=5) daily for 1 month. Stool samples will be collected after 1 week and again after 1 month. A final stool sample will be collected 1 month after stopping the omeprazole. A stool sample will be collected from the CDI subjects before treatment of the infection and again 2 months after treatment to avoid enrolling those at risk for relapse (which most commonly occurs during the first 2 months after treatment).
- Primary Outcome Measures
Name Time Method Changes in fecal microbial diversity due to PPI therapy 2 months
- Secondary Outcome Measures
Name Time Method Changes in fecal microbial diversity due to CDI 2 months
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States