NCT02844621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P50-P75 for early_phase_1 healthy-volunteers

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 20, 2017

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

July 15, 2016

Last Update Submit

January 19, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in interleukin inflammatory markers following omeprazole use

    14 days

  • Change in tumor necrosis factor-alpha following omeprazole use

    14 days

  • Change in insulin-like growth factor-1 due following omeprazole use

    14 days

Study Arms (1)

Healthy subjects

EXPERIMENTAL
Drug: Omeprazole

Interventions

OmeprazoleDRUG

20mg orally once daily

Healthy subjects

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Outpatient Research Unit, Medical Arts and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kelly R Reveles, PharmD, PhD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 26, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 20, 2017

Record last verified: 2016-07

Locations

US(1)