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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI inititation | Experimental | Adding 40mg omeprazole QD for 14 days |
|
| PPI withdrawal | Active Comparator | The intervention here is systematically withdrawing chronic PPI for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 20mg PO BID for 20 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for PPI initiation study:
Exclusion Criteria for PPI initiation study:
Inclusion Criteria for PPI withdrawal study:
Exclusion Criteria for PPI withdrawal study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25258407 | Result | 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. | |
| 37937851 |
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Participants recruited from McGuire VAMC hepatology clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | PPI Inititation | Adding 40mg omeprazole QD for 14 days |
| FG001 | PPI Withdrawal | The intervention here is systematically withdrawing chronic PPI for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PPI Inititation | Adding 40mg omeprazole QD for 14 days |
| BG001 | PPI Withdrawal | The intervention here is systematically withdrawing chronic PPI for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Count of Participants | Participants | 2 weeks |
|
During study period of 14 days
Standard definitions used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PPI Inititation | Adding 40mg omeprazole QD for 14 days | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasmohan Bajaj | Hunter Holmes McGuire VA Medical Center | 804 675 5802 | jasmohan.bajaj@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2017 | Dec 19, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2017 | Dec 19, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
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| Derived |
| 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. |
| 29515036 | Derived | 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. |
| 28578302 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PPI Withdrawal |
The intervention here is systematically withdrawing chronic PPI for 14 days Omeprazole: 20mg PO BID for 20 days |
|
|
| 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 | No safety or tolerability issues were seen during the study | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | PPI Withdrawal | The intervention here is systematically withdrawing chronic PPI for 14 days | 0 | 15 | 0 | 15 | 0 | 15 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |