Status:
COMPLETED
Effects of Gastric Acid on Colonic Microbiome
Lead Sponsor:
Daniel Freedberg, MD
Conditions:
Clostridium Difficile
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The colonic microbiome is essential in human health and disease. Clostridium difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused by antibiotics which perturb t...
Detailed Description
Study Design We will recruit 12 adult volunteers for a crossover study with a total duration of 12 weeks. Subjects will be observed off of PPIs for 4 weeks and then will be placed on PPIs for 4 weeks....
Eligibility Criteria
Inclusion
- 18 or more years old
- Able to give informed consent
Exclusion
- Use of systemic antibiotics within the past year
- Use of acid suppression medications (PPIs or H2-receptor antagonists) within the past year (antacids permitted if more than one month from date of enrollment)
- History of chronic gastrointestinal mucosal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis)
- Any clinically significant or uncontrolled major morbidity, including but not limited to serious cardiac or respiratory disease or uncontrolled HIV
- Abnormal bowel frequency (minimum once every 2 days, maximum 3 times per day)
- Use of clopidogrel or medications with potential significant interaction with PPIs
- Osteoperosis or history of non-traumatic bone fracture
- History of adverse reactions to PPIs
- Initiation of any new medication within the month prior to enrollment
- Pregnancy
- Inability to give informed consent
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01901276
Start Date
August 1 2013
End Date
March 1 2015
Last Update
August 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032