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

January 19, 2017 updated by: The University of Texas Health Science Center at San Antonio

Comparison of Gut Microbiota Composition and Systemic Inflammatory Markers Prior to and Post-Proton Pump Inhibitor Use in Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • First Outpatient Research Unit, Medical Arts and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Healthy subjects
Drug: Omeprazole
20mg orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Kelly R Reveles, PharmD, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20160114H

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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