- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901276
Effects of Gastric Acid on Colonic Microbiome
The Effects of Gastric Acid Suppression on the Colonic Microbiome
Study Overview
Status
Conditions
Intervention / Treatment
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. Subsequently, subjects will be randomized to receive an additional 4 weeks of PPIs or no therapy. Stool samples will be collected at 4 separate time points.
Study Outcomes and Statistical Analyses The primary outcome will be change in overall diversity of fecal flora after 4 weeks of PPIs compared to 4 weeks of no acid suppression. Additional outcomes to be assessed include the effect of PPIs on the relative abundance of Bacteroidetes at week 4 and change in the diversity of fecal flora at week 8.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 or more years old
- Able to give informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omeprazole 40 mg bid x 4-8 weeks
See study description for further details.
|
As above.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome diversity
Time Frame: 4 weeks
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In order to assess the diversity of the colonic microbiome, three Bray-Curtis indices will be calculated for each subject:
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julian A Abrams, MD, MS, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAL3307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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