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Proton Pump Inhibitors and Dysbiosis in Cirrhosis

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ClinicalTrials.gov Identifier: NCT01458990
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Cirrhosis Healthy Drug: Omeprazole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2011
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PPI inititation
Adding 40mg omeprazole QD for 14 days
Drug: Omeprazole
20mg PO BID for 20 days
Active Comparator: PPI withdrawal
The intervention here is systematically withdrawing chronic PPI for 14 days
Drug: Omeprazole
20mg PO BID for 20 days



Primary Outcome Measures :
  1. Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation [ Time Frame: 2 weeks ]
    Analysis at baseline will be compared to that at 2 weeks using Multitagged sequencing. Number of patients with overgrowth of oral microbiota in their stool after PPI therapy withdrawal or initiation were specifically analyzed.


Secondary Outcome Measures :
  1. Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy [ Time Frame: 2 weeks ]
    Analysis at baseline will be compared to that at 2 weeks. This will be specifically, changes in those with PPI withdrawal compared to those with PPI initiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for PPI initiation study:

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

Exclusion Criteria for PPI initiation study:

  • On systemic antibiotics
  • On PPI or acid suppression therapy already
  • unable to give informed consent
  • Allergy to proton pump inhibitors

Inclusion Criteria for PPI withdrawal study:

  • Cirrhosis on current PPI for an FDA-unapproved indication
  • No systemic antibiotics or probiotics

Exclusion Criteria for PPI withdrawal study:

  • On systemic absorbable antibiotics
  • On PPI or acid suppression therapy for an FDA-approved indication
  • unable to give informed consent
  • unwilling to withdraw PPI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  Study Documents (Full-Text)

Documents provided by Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center:
Study Protocol  [PDF] November 29, 2017
Statistical Analysis Plan  [PDF] November 29, 2017


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: October 25, 2011    Key Record Dates
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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