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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02844621

HSC20160114H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Healthy subjects

Experimental group

Treatment:

Drug: Omeprazole