CirrhosisNCT01458990

Proton Pump Inhibitors and Dysbiosis in Cirrhosis

A study testing Omeprazole in people with Cirrhosis and Healthy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cirrhosis, Healthy
What is being tested?: Omeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cirrhosis not on current PPI or acid suppressive therapy
No systemic antibiotics or probiotics
Cirrhosis on current PPI for an FDA-unapproved indication
No systemic antibiotics or probiotics

Who cannot join

On systemic antibiotics
On PPI or acid suppression therapy already
unable to give informed consent
Allergy to proton pump inhibitors
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 locations and contacts

1 site in 1 country.

United States1 site

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249

Other trials in United States

About this study

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.

Conditions: Cirrhosis, Healthy
Being tested: Omeprazole
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmeprazoleDrug
20mg PO BID for 20 days

Study groups in NCT01458990
Study group	Role	What they receive
PPI inititation	Experimental	Adding 40mg omeprazole QD for 14 days Receives: Drug: Omeprazole
PPI withdrawal	Active comparator	The intervention here is systematically withdrawing chronic PPI for 14 days Receives: Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks

Secondary outcomes (1)

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
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Feb 2018

First posted25 Oct 2011 (estimated)
Study startOct 2011
Primary completionFeb 2018
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Model description: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01458990
Sponsor's protocol ID: BAJAJ004
Status last verified: Mar 2018
First submitted: 21 Oct 2011
Last updated: 19 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

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.
PubMed 25258407
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.
PubMed 37937851
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.
PubMed 29515036
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.
PubMed 28578302

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proton Pump Inhibitors and Dysbiosis in Cirrhosis
ClinicalTrials.gov ID: NCT01458990
Acronym / sponsor ID: BAJAJ004
Conditions: Cirrhosis, Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
Study start: Oct 2011
Primary completion: Feb 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 25 Oct 2011 (estimated)
Results: Posted 19 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)

Arm	Type	Receives
PPI inititation	Experimental	Drug: OmeprazoleAdding 40mg omeprazole QD for 14 days
PPI withdrawal	Active comparator	Drug: OmeprazoleThe intervention here is systematically withdrawing chronic PPI for 14 days

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Cirrhosis not on current PPI or acid suppressive therapy
No systemic antibiotics or probiotics
Cirrhosis on current PPI for an FDA-unapproved indication
No systemic antibiotics or probiotics

Key exclusion criteria (8 listed)

On systemic antibiotics
On PPI or acid suppression therapy already
unable to give informed consent
Allergy to proton pump inhibitors
On systemic absorbable antibiotics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omeprazole20mg PO BID for 20 days	Drug	PPI inititation, PPI withdrawal

Primary outcome

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.

1 secondary outcome

Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy
Time frame: 2 weeks

Results and safety

Results posted to the registry on 19 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PPI Inititation	45	45
PPI Withdrawal	15	15

Primary outcome: Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	PPI Inititation n = 45	PPI Withdrawal n = 15
Value	45	15

Population analysed: Comparison were made between groups on/off PPI therapy using Linear discriminant analysis effect size (LEFSe) and using the Quantitative Insights Into Microbial Ecology (QIIME) pipeline and also the relative proportion (%) of oral-origin microbiota were studied

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During study period of 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PPI Inititation	0 of 45 (0%)	0 of 45 (0%)	0 of 45
PPI Withdrawal	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25258407Bajaj 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.
Derived from this study: PubMed 37937851Pena 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.
Derived from this study: PubMed 29515036Bajaj 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.
Derived from this study: PubMed 28578302Bajaj 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.
Individual participant dataSharing planned: Undecided

Related trials for Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
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Recruiting
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Omeprazole in people with Cirrhosis and Healthy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01458990, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.