Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Hunter Holmes Mcguire Veteran Affairs Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cirrhosis Healthy

Interventions

OmeprazoleDRUG

20mg PO BID for 20 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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