Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults
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|ClinicalTrials.gov Identifier: NCT02844621|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : January 20, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Omeprazole||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Comparison of Gut Microbiota Composition and Systemic Inflammatory Markers Prior to and Post-Proton Pump Inhibitor Use in Older Adults|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|Experimental: Healthy subjects||
20mg orally once daily
- Change in fecal microbiota diversity following omeprazole use [ Time Frame: 14 days ]Bacterial taxa will be classified according to operational taxonomic units (OTUs). The change in the diversity of bacteria taxa will be compared between pre- and post-samples using the Bray-Curtis dissimilarity measure.
- Change in interleukin inflammatory markers following omeprazole use [ Time Frame: 14 days ]Interleukin 2, interleukin-6, and interleukin-10 will be measured from the blood at baseline and following omeprazole use and each reported in pg/mL.
- Change in tumor necrosis factor-alpha following omeprazole use [ Time Frame: 14 days ]Tumor necrosis factor-alpha will be measured from the blood at baseline and following omeprazole use and reported in pg/mL.
- Change in insulin-like growth factor-1 due following omeprazole use [ Time Frame: 14 days ]Insulin-like growth factor-1 will be measured from the blood at baseline and following omeprazole use and reported in ng/mL.
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|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age 60 years or older
- No prior major gastrointestinal surgery
- No chronic daily use or any use within the past two months of the following medications: antibiotics, proton pump inhibitors, other acid reflux medications, probiotics, anti-inflammatory medications, anti-diarrhea medications, laxatives, anti-depressants, anti-anxiety medications, steroids, metformin, or biologic/immune modulating drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844621
|United States, Texas|
|First Outpatient Research Unit, Medical Arts and Research Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Kelly R Reveles, PharmD, PhD||The University of Texas Health Science Center at San Antonio|
|Responsible Party:||The University of Texas Health Science Center at San Antonio|
|Other Study ID Numbers:||
|First Posted:||July 26, 2016 Key Record Dates|
|Last Update Posted:||January 20, 2017|
|Last Verified:||July 2016|
Proton Pump Inhibitors
Molecular Mechanisms of Pharmacological Action