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Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844621
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Omeprazole Early Phase 1

Detailed Description:
This study aims to enroll 25 healthy subjects from San Antonio, Texas and the surrounding area. Study participants will be asked to provide a blood and stool sample at baseline, complete a 14-day course of omeprazole (Prilosec®), and then complete a follow-up blood and stool sample.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arm Intervention/treatment
Experimental: Healthy subjects Drug: Omeprazole
20mg orally once daily




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 60 years or older

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Texas
First Outpatient Research Unit, Medical Arts and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Kelly R Reveles, PharmD, PhD The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02844621    
Other Study ID Numbers: HSC20160114H
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: July 2016
Additional relevant MeSH terms:
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Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action