Proton Pump Inhibitors and Dysbiosis in Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01458990
First received: October 21, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to find out whether the use of medications that suppress acid in your stomach can change the composition of your bowel bacteria.


Condition Intervention
Cirrhosis
Healthy
Drug: Omeprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Primary Outcome Measures:
  • Stool microflora change [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Analysis at baseline will be compared to that at 2 weeks


Secondary Outcome Measures:
  • Sigmoid mucosal microflora change [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Analysis at baseline will be compared to that at 2 weeks


Estimated Enrollment: 50
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label Drug: Omeprazole
20mg PO BID for 20 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cirrhosis or healthy controls not on current PPI or acid suppressive therapy
  • No systemic antibiotics or probiotics

Exclusion Criteria:

  • On systemic antibiotics
  • On PPI or acid suppression therapy already
  • unable to give informed consent
  • Allergy to proton pump inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458990

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
  More Information

No publications provided

Responsible Party: Jasmohan Bajaj, Associate Professor, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01458990     History of Changes
Other Study ID Numbers: BAJAJ004
Study First Received: October 21, 2011
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014