Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PPI inititation

Adding 40mg omeprazole QD for 14 days

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

20mg PO BID for 20 days

PPI withdrawal

The intervention here is systematically withdrawing chronic PPI for 14 days

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

20mg PO BID for 20 days

Interventions

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Omeprazole

20mg PO BID for 20 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

* Cirrhosis on current PPI for an FDA-unapproved indication
* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No