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OpenTrials
Completed

NCT Number: NCT02844621

Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation 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.

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Key information

Conditions

Healthy Volunteers

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

First Outpatient Research Unit, Medical Arts and Research Center

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

20mg orally once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2016
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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