Cirrhosis, Healthy
Conditions
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.
Interventions
DRUGOmeprazole
20mg PO BID for 20 days
Sponsors
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy | 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 |
Countries
United States
Participant flow
Recruitment details
Participants recruited from McGuire VAMC hepatology clinics
Participants by arm
| Arm | Count |
|---|---|
| PPI Inititation Adding 40mg omeprazole QD for 14 days | 45 |
| PPI Withdrawal The intervention here is systematically withdrawing chronic PPI for 14 days | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | PPI Withdrawal | Total | PPI Inititation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 54 Participants | 40 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 6.7 | 58 years STANDARD_DEVIATION 7 | 58 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 22 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 38 Participants | 29 Participants |
| Region of Enrollment United States | 15 participants | 60 participants | 45 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 56 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 15 |
| other Total, other adverse events | 0 / 45 | 0 / 15 |
| serious Total, serious adverse events | 0 / 45 | 0 / 15 |
Outcome results
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.
Time frame: 2 weeks
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PPI Inititation | Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation | 45 Participants |
| PPI Withdrawal | Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation | 15 Participants |
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
Time frame: 2 weeks
Population: No safety or tolerability issues were seen during the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PPI Inititation | Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy | 0 Participants |
| PPI Withdrawal | Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy | 0 Participants |