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

Early Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Omeprazole

• Registration Number: NCT02844621
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Omeprazole	-

Primary Outcome Measures

Name	Time	Method
Change in fecal microbiota diversity following omeprazole use	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

Name	Time	Method
Change in interleukin inflammatory markers following omeprazole use	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	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	14 days	Insulin-like growth factor-1 will be measured from the blood at baseline and following omeprazole use and reported in ng/mL.

Trial Locations

Locations (1)

First Outpatient Research Unit, Medical Arts and Research Center; 🇺🇸 San Antonio, Texas, United States