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Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Primary Purpose

Cirrhosis, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PPI inititation

PPI withdrawal

Arm Description

Adding 40mg omeprazole QD for 14 days

The intervention here is systematically withdrawing chronic PPI for 14 days

Outcomes

Primary Outcome Measures

Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation
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

Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy
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

Full Information

First Posted
October 21, 2011
Last Updated
March 14, 2018
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01458990
Brief Title
Proton Pump Inhibitors and Dysbiosis in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Healthy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPI inititation
Arm Type
Experimental
Arm Description
Adding 40mg omeprazole QD for 14 days
Arm Title
PPI withdrawal
Arm Type
Active Comparator
Arm Description
The intervention here is systematically withdrawing chronic PPI for 14 days
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
20mg PO BID for 20 days
Primary Outcome Measure Information:
Title
Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25258407
Citation
Bajaj JS, Cox IJ, Betrapally NS, Heuman DM, Schubert ML, Ratneswaran M, Hylemon PB, White MB, Daita K, Noble NA, Sikaroodi M, Williams R, Crossey MM, Taylor-Robinson SD, Gillevet PM. Systems biology analysis of omeprazole therapy in cirrhosis demonstrates significant shifts in gut microbiota composition and function. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 15;307(10):G951-7. doi: 10.1152/ajpgi.00268.2014. Epub 2014 Sep 25.
Results Reference
result
PubMed Identifier
29515036
Citation
Bajaj JS, Thacker LR, Fagan A, White MB, Gavis EA, Hylemon PB, Brown R, Acharya C, Heuman DM, Fuchs M, Dalmet S, Sikaroodi M, Gillevet PM. Gut microbial RNA and DNA analysis predicts hospitalizations in cirrhosis. JCI Insight. 2018 Mar 8;3(5):e98019. doi: 10.1172/jci.insight.98019.
Results Reference
derived
PubMed Identifier
28578302
Citation
Bajaj JS, Liu EJ, Kheradman R, Fagan A, Heuman DM, White M, Gavis EA, Hylemon P, Sikaroodi M, Gillevet PM. Fungal dysbiosis in cirrhosis. Gut. 2018 Jun;67(6):1146-1154. doi: 10.1136/gutjnl-2016-313170. Epub 2017 Jun 3.
Results Reference
derived

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Proton Pump Inhibitors and Dysbiosis in Cirrhosis

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