Clostridium Difficile Infection, Healthy
Conditions
Keywords
gut microbiota, proton pump inhibitor, Clostridium difficile infection, Fecal microbiome, single episode of CDI
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).
Interventions
DRUGomeprazole
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Table 1. Inclusion Criteria for Healthy Volunteers: 1\. Healthy individuals without chronic gastrointestinal problems or using antisecretory medications. Table 2. Inclusion Criteria for Clostridium difficile infection subjects: 1\. Newly diagnosed first episode of CDI prior to being treated. Table 3.
Exclusion criteria
for Healthy Subjects: 1. Prior gastrointestinal surgery that has altered the anatomy of the esophagus, stomach, or small/large intestine including appendectomy and cholecystectomy. 2. Chronic daily use of any medications that could alter gastrointestinal secretory or motor function (see Table 2). 3. Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus). 4. Females of childbearing age who are not practicing at least one form of birth control at least one month prior to starting the PPI or are pregnant or lactating (a pregnancy test will be performed on female subjects prior to PPI use). 5. Significant untreated psychiatric disease. Table 4. Prohibited Medications: 1. Antibiotics within 2 months of the stool sample collection. 2. Probiotics (e.g., Florastor, Align, Flora-Q, VSL#3, lactobacillus, bifidobacterium) within 2 weeks of the stool sample collection. 3. Fiber supplements (e.g., Metamucil, Citrucel, Benefiber), unless maintained on a stable dose for the last 3 months. 4. Chronic use of medications that alter gastric pH: proton pump inhibitors (e.g., omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole) and histamine2 receptor antagonists (e.g., cimetidine, famotidine, ranitidine). 5. Chronic use of medications that affect gastrointestinal motility and/or transit including prokinetic agents (e.g., metoclopramide (Reglan), tegaserod (Zelnorm), domperidone (Motilium), erythromycin), narcotic analgesic agents (e.g., methadone, fentanyl, oxycodone, codeine, morphine, hydromorphone), laxatives including mineral oil, anticholinergic agents (e.g., Bentyl, Levsin), and antidiarrheal agents (e.g., Kaopectate (donnagel), Pepto-Bismol (bismuth subsalicylate), Imodium (loperamide), Lomotil (atropine with diphenoxylate), codeine, tincture of opium).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fecal microbial diversity due to PPI therapy | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fecal microbial diversity due to CDI | 2 months |
Countries
United States
Outcome results
None listed