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OpenTrials
Completed

NCT Number: NCT01458990

Proton Pump Inhibitors and Dysbiosis in Cirrhosis

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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Key information

Conditions

Cirrhosis Fibrosis Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

20mg PO BID for 20 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2011
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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