NCT01458990

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

6.3 years

First QC Date

October 21, 2011

Results QC Date

November 29, 2017

Last Update Submit

March 14, 2018

Conditions

CirrhosisHealthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy

    2 weeks

Study Arms (2)

PPI inititation

EXPERIMENTAL

Adding 40mg omeprazole QD for 14 days

Drug: Omeprazole

PPI withdrawal

ACTIVE COMPARATOR

The intervention here is systematically withdrawing chronic PPI for 14 days

Drug: Omeprazole

Interventions

OmeprazoleDRUG

20mg PO BID for 20 days

PPI inititationPPI withdrawal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • On systemic antibiotics
  • On PPI or acid suppression therapy already
  • unable to give informed consent
  • Allergy to proton pump inhibitors
  • Cirrhosis on current PPI for an FDA-unapproved indication
  • No systemic antibiotics or probiotics
  • On systemic absorbable antibiotics
  • On PPI or acid suppression therapy for an FDA-approved indication
  • unable to give informed consent
  • unwilling to withdraw PPI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (4)

  • 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 significant shifts in gut microbiota composition and function. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 15;307(10):G951-7. doi: 10.1152/ajpgi.00268.2014. Epub 2014 Sep 25.

    PMID: 25258407RESULT

  • Pena Rodriguez M, Fagan A, Sikaroodi M, Gillevet PM, Bajaj JS. Proton Pump Inhibitor Use and Complications of Cirrhosis Are Linked With Distinct Gut Microbial Bacteriophage and Eukaryotic Viral-Like Particle Signatures in Cirrhosis. Clin Transl Gastroenterol. 2024 Feb 1;15(2):e00659. doi: 10.14309/ctg.0000000000000659.

    PMID: 37937851DERIVED

  • Bajaj JS, Thacker LR, Fagan A, White MB, Gavis EA, Hylemon PB, Brown R, Acharya C, Heuman DM, Fuchs M, Dalmet S, Sikaroodi M, Gillevet PM. Gut microbial RNA and DNA analysis predicts hospitalizations in cirrhosis. JCI Insight. 2018 Mar 8;3(5):e98019. doi: 10.1172/jci.insight.98019.

    PMID: 29515036DERIVED

  • Bajaj JS, Liu EJ, Kheradman R, Fagan A, Heuman DM, White M, Gavis EA, Hylemon P, Sikaroodi M, Gillevet PM. Fungal dysbiosis in cirrhosis. Gut. 2018 Jun;67(6):1146-1154. doi: 10.1136/gutjnl-2016-313170. Epub 2017 Jun 3.

    PMID: 28578302DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Jasmohan Bajaj
Organization
Hunter Holmes McGuire VA Medical Center
jasmohan.bajaj@va.gov
804 675 5802

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 19, 2018

Results First Posted

March 19, 2018

Record last verified: 2018-03

Locations

US(1)