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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844621
• Other study ID #: HSC20160114H
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: January 19, 2017
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Omeprazole
20mg orally once daily

Locations

Country	Name	City	State
United States	First Outpatient Research Unit, Medical Arts and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fecal microbiota diversity following omeprazole use	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	Change in interleukin inflammatory markers following omeprazole use	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
Secondary	Change in tumor necrosis factor-alpha following omeprazole use	Tumor necrosis factor-alpha will be measured from the blood at baseline and following omeprazole use and reported in pg/mL.	14 days
Secondary	Change in insulin-like growth factor-1 due following omeprazole use	Insulin-like growth factor-1 will be measured from the blood at baseline and following omeprazole use and reported in ng/mL.	14 days