Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status: Completed

Conditions: Healthy; Cirrhosis

Treatments: Drug: Omeprazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01458990

BAJAJ004

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PPI inititation

Experimental group

Description:

Adding 40mg omeprazole QD for 14 days

Treatment:

Drug: Omeprazole

PPI withdrawal

Active Comparator group

Description:

The intervention here is systematically withdrawing chronic PPI for 14 days

Treatment:

Drug: Omeprazole