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

• ClinicalTrials.gov Identifier: NCT02844621
• Recruitment Status: Completed
• First Posted: July 26, 2016
• Last Update Posted: January 20, 2017
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Tracking Information

• First Submitted Date: July 15, 2016
• First Posted Date: July 26, 2016
• Last Update Posted Date: January 20, 2017
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 21, 2016)

Change in fecal microbiota diversity following omeprazole use [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 21, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults
• Official Title: Comparison of Gut Microbiota Composition and Systemic Inflammatory Markers Prior to and Post-Proton Pump Inhibitor Use in Older Adults
• 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 Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Volunteers

Intervention

Drug: Omeprazole

20mg orally once daily

Study Arms

Experimental: Healthy subjects

Intervention: Drug: Omeprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2016): 25
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02844621
• Other Study ID Numbers: HSC20160114H
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: The University of Texas Health Science Center at San Antonio
• Study Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kelly R Reveles, PharmD, PhD; The University of Texas Health Science Center at San Antonio

• PRS Account: The University of Texas Health Science Center at San Antonio
• Verification Date: July 2016