Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458990
• Other study ID #: BAJAJ004
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: March 14, 2018
• Start date: October 2011
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Healthy
• Liver Cirrhosis

Intervention

Drug:
• Omeprazole
20mg PO BID for 20 days

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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	2 weeks