Healthy Volunteers
Conditions
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.
Interventions
DRUGOmeprazole
20mg orally once daily
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed